THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rodwelch@pacbell.net


S U M M A R Y


DIARY: March 15, 2007 08:15 AM Thursday; Rod Welch

Millie at UCSF 2nd cycle 3rd treatment Cetuximab for IBC relapse.

1...Summary/Objective
2...Clinic Examination Orientation Starting Treatment Cetuximab
3...Breast Examination Likely IBC 2 Scenarios Spreading Intensity Declines
4...Coordination Kaiser Schedule CT Test Effective
5...CT Test Scheduled Meets Clinical Study Requirements Start Next Cycle
6...Emotional Roller Coaster Endemic Cancer Treatment and Coordination
7...Weekly Treatments Tolerating Constant Interrutions of Life
8...Vacation 2 Weeks Occassional Flexibility Advance Delay Treatments
9...Flexibility Advance Delay Treatments 1 Day Accomodate Exigent Issues
10...Cetuximab Prognosis IBC May Subside for 10 Months Before Progressing
11...Prognosis Disease May Subside 10 Months or More Before Progression
12...Progresssion of Disease May be Delayed for 10 Months or More
13...Measureable Disease Photographs IBC Rash Improving
14...IBC Rash Improved Measurable Disease Photographs Tape Measure
15...Side Effects Medicated After Weekly Examinations
16...Blood Tests 1 Per Month on Cetuximab Performed at UCSF Saves Time Cost
17...INR 2.5 Low Pulmonary Embolism Needs Increase Coumadin Treatment
18...Pulmonary Embolism Treatment Coumadin Needs Increase Low INR 2.5
19...Infusion Clinic for Cetuximab Treatment
..........Taxotere Capecitabine Started 060721 Ended 061201
..........Cetuxiab Clinical Study Started 070201
20...Nurses Notes...
21...Side Effects Consultation Pharmacist Heavy Chest Difficult Breathing
22...Schedule Weekly Treatments Continue on Thursdays
23...Blood Counts Normal Full Dose Cetuximab Ordered
24...Blood Test Not Scheduled Infusion Clinic Took Approprite Action
25...Coagulation Control INR High 2.5 PT 28 High
26...ANC 1510 Below 1800 Criteria for Blood Counts to Approve Treatment
27...CA 15-3 36 Tests 2 From Kaiser 1 from UCSF Pending Submission
28...Preparation for Treatment Required One (1) Attempt to Connect Port
29...Blood Draws 7 Vials for Clinical Study Research
30...Benedryl Reduce Side Effects Cetuximab Chemotherapy Treatment
31...Cetuximab Full Dose Blood Counts on Targets Treatment 1 Hour
32...Vitals Show Patient Stable
33...Energy Normal Stable After Treatment Cetuximab Support Drugs

ACTION ITEMS.................. Click here to comment!

1...The next blood test is scheduled for 070329.
2...The next blood test is scheduled for 070329.

CONTACTS 

SUBJECTS
Examination Treatment Cetuximab 3rd Treatment 2nd Cycle Chemotherapy

0603 -
0603 -    ..
0604 - Summary/Objective
0605 -
060501 - Follow up ref SDS E8 0000. ref SDS E5 0000.
060502 -
060503 - Examination today shows further response to treatment with IBC rash
060504 - subsiding, and no further spread of disease. ref SDS 0 FO6H  UCSF
060505 - submitted a new schedule today for examinations and treatments.  The
060506 - schedule needs review adding blood tests to start new cycles.
060507 - ref SDS 0 QK6L  For some reason, there was no treatment scheduled
060508 - today.  Infusion Clinic staff took immediate action to minimize delay
060509 - and stress making arrangements. ref SDS 0 1M6H  Brigid asked about
060510 - emotional stress coping with big changes the past few weeks in
060511 - assessment of Millie's cancer. ref SDS 0 6A7J  Emotional swings also
060512 - occur from complex communications coordinating examinations, tests and
060513 - treatment, indicated by work today. ref SDS 0 OR5K  Absorbing mounting
060514 - stress with calm resolve and steady focus is aided by excellent care
060515 - at Kaiser and UCSF, which shields Millie from worry about analysis,
060516 - planning, and coordination. ref SDS 0 6A8L  Millie was heartened
060517 - hearing today that prognosis for current response to treatment may
060518 - last for more than 10 months. ref SDS 0 6A9H  Quality of life with
060519 - weekly treatments on the cetuximab clinical study requires tolerance
060520 - and innovation designing studies that test response to less frequent
060521 - treatments. ref SDS 0 6A4J  Millie has been fortunate that so far side
060522 - effects are mild, ref SDS 0 FO66; most notably there is a sea change
060523 - in higher energy that has increased qualify of life while also
060524 - providing effective treatment of IBC. ref SDS 0 J18M
060525 -
060526 -
060527 -
060528 -
060529 -
060531 -  ..
0606 -
0607 -
0608 - Progress
0609 -
060901 - Clinic Examination Orientation Starting Treatment Cetuximab
060902 -
060903 - Follow up ref SDS E8 407N, ref SDS E5 407N.
060904 -
060905 - This is the regularly scheduled interim examination performed by
060906 - Brigid and assisted by Jackie, and required for the cetuximab clinical
060907 - study.  Once a month, Doctor Rugo makes an examination, as occurred on
060908 - 070301. ref SDS E3 025H
060910 -  ..
060911 - Agenda...
060912 -
060913 -    1.  Breast examination........................ ref SDS 0 FO6H
060914 -    2.  CT test scheduled 070326.................. ref SDS 0 OG6G
060915 -    3.  Emotional coping with cancer.............. ref SDS 0 6A7J
060916 -    4.  Estimate Time to Progression.............. ref SDS 0 6A9H
060917 -    5.  Infusion Clinic........................... ref SDS 0 1M6H
060918 -    6.  Side effects.............................. ref SDS 0 QU8K
060920 -  ..
060921 - Jackie said that she can no longer schedule meetings for Millie.
060923 -  ..
060924 - UCSF is using a new procedure for patients to coordinate with staff at
060925 - the front desk in the Breast Care Center reception area for scheduling
060926 - meetings.
060928 -  ..
060929 - Brigid gave Millie a document requesting that the staff schedule
060930 - meetings over the next 3 - 4 months.
060931 -
060932 -     [On 070510 scheduled another 8 weeks of meetings and treatments.
060933 -     ref SDS F7 9L9N
060935 -  ..
060936 - After the meeting, Millie went to the Infusion Clinic for treatment,
060937 - while the Breast Care Center staff worked on scheduling meetings with
060938 - Doctor Rugo, Brigid, and Jackie.  The medical assistant was very
060939 - helpful and effective setting times in the early morning.  This was at
060940 - first problematic for dates when Doctor Rugo meets with Millie once a
060941 - month.  Since Doctor Rugo leverages her time with support from Brigid
060942 - and Jackie, the MA worked out a schedule, shown below, to give the
060943 - doctor flexibility reviewing Millie's case during the meeting period,
060944 - without allocating the entire time. ref SDS 0 QK6L
060946 -  ..
060947 - Review of the schedule for examinations and treatments shown below,
060948 - indicates coordination is needed to include blood tests. ref SDS 0
060949 - QK6L
060950 -
060951 -            [On 070510 UCSF submitted updated schedule of meetings and
060952 -            treatments. ref SDS F7 CQ4I
060953 -
060954 -
060955 -
060956 -
0610 -

SUBJECTS
Breast Examination Shows Improvement IBC Rash Intensity Subsides No

1203 -
120401 -  ..
120402 - Breast Examination Likely IBC 2 Scenarios Spreading Intensity Declines
120403 -
120404 - Follow up ref SDS E8 FO6H, ref SDS E5 FO6H.
120405 -
120406 - Brigid was very pleased that weekly treatments seem to be reducing
120407 - intensity of IBC rash primarily on the left chest, but now spread
120408 - slightly onto the right breast, to the left arm, stomach, and back,
120409 - reported during examination on 070301. ref SDS E3 4140  Examination
120410 - today indicates all sites continue to subside, which reflects response
120411 - to treatment with cetuximab.  Millie again asked about lightly
120412 - sprinkled red dots on the inner, upper right arm.  Brigid seems to
120413 - still feel this is not IBC, also, noted on 070301. ref SDS E3 H15M
120415 -          ..
120416 -         [On 070322 Millie asked Catherine in the Infusion Clinic to
120417 -         look at the right arm, and at that time there was no
120418 -         discernable pattern of rash. ref SDS F1 LI4M
120420 -  ..
120421 - Brigid noted there are no new IBC sites evident by examination today,
120422 - based on the list reported during the meeting with Doctor Rugo on
120423 - 070301. ref SDS E4 LB5L  She asked how many treatments Millie has had
120424 - including today?  Patient history shows that today will be the 7th
120425 - treatment with cetuximab, since starting on the clinical study on
120426 - 070201, per below. ref SDS 0 7T3H
120427 -
120428 -        [...below, Nola said that Millie is not scheduled for treatment
120429 -        today; this was ultimately arranged. ref SDS 0 1M6H
120431 -  ..
120432 - Finding that intensity of IBC rash has declined aligns with cancer
120433 - marker CA 15-3 36 suddenly falling to the lowest level in over a year,
120434 - reported on 070307, ref SDS E6 U85L, and cited in the record for
120435 - treatment last week on 070308, ref SDS E7 2N5J, as the basis for
120436 - Doctor Rugo cancelling the meeting scheduled to consider changing the
120437 - treatment to increase effectiveness. ref SDS E7 PN6M and
120438 -
120439 -
120440 -
120441 -
1205 -

SUBJECTS
CT Test Scheduled 070326 Meets Clinical Study Requirements Start Nex

2003 -
200401 -  ..
200402 - Coordination Kaiser Schedule CT Test Effective
200403 - CT Test Scheduled Meets Clinical Study Requirements Start Next Cycle
200404 -
200405 - Follow up ref SDS F0 DT4I, ref SDS E4 N96O.
200406 -
200407 - Brigid advised that UCSF received Millie's letter, ref DIP 1 0001,
200408 - submitted yesterday, on 070314, ref SDS F0 UN6M, and notifying that
200409 - work was completed coordinating Kaiser to schedule the next CT test on
200410 - 070326, as requested in the UCSF order submitted by Brigid a few weeks
200411 - ago on 070301. ref SDS E4 UR9J  Brigid indicated today that getting
200412 - the test done on 070326 will provide enough time for Kaiser to prepare
200413 - a report and submit to UCSF in time for the doctor to review and
200414 - prepare for meeting with Millie on 070329.
200416 -  ..
200417 - Jackie recalled planning coordination on 070301 to schedule CT tests
200418 - at Kaiser. ref SDS E4 EY5O  At that time Brigid noted that patient
200419 - coordination saves UCSF a lot of time and effort. ref SDS E4 O67N
200420 - Case study on 070307 showing steps to coordinate the schedule for the
200421 - CT test on 070326 indicates that Brigid's analysis was correct.
200422 - ref SDS E7 G56L
200423 -
200424 -
200425 -
200426 -
200427 -
2005 -

SUBJECTS
Emotional Stress Roller Coaster Endemic Cancer Treatment Erratic Cha

2503 -
250401 -  ..
250402 - Emotional Roller Coaster Endemic Cancer Treatment and Coordination
250403 -
250404 - Follow up ref SDS E4 Y642.
250405 -
250406 - Brigid asked Millie about coping emotionally with major changes the
250407 - past few weeks in assessment of treatment?  The doctor discussed
250408 - changing treatment on 070301 because treatment has failed to stop
250409 - cancer from spreading, ref SDS E4 LB5L; a week later a big meeting is
250410 - cancelled without notice, ref SDS E8 FO6H, in complete confidence the
250411 - same treatment is a big success. ref SDS E8 7N4N
250412 -
250413 -     [On 070322 new side effect difficulty sleeping. ref SDS F1 NG4N
250415 -  ..
250416 - Emotional trauma living with cancer, including weekly treatments
250417 - raised below, ref SDS 0 6A4J, is reviewed for monthly meetings that
250418 - start a new cycle, most recently on 070301. ref SDS E4 Y642  Weekly
250419 - treatments are an emotional burden adjusting to demands of constancy.
250420 - This may lessen from weaving activities over time toward survival and
250421 - quality of life.  Emotions necessarily rise from concern toward panic,
250422 - as cancer spreads to new sites, reviewed on 070301. ref SDS E4 LB5L
250423 - Millie said this morning that feelings of worry and doubt that falling
250424 - ANC blood counts would prevent getting effective treatment at that
250425 - time on 070301, ref SDS E4 D24M, were relieved, and spirits were
250426 - boosted by news that the cancer marker CA 15-3 improved dramatically,
250427 - to the best condition in over a year, reported a week ago on 070307,
250428 - ref SDS E7 U85L  Further relief occurred the next day on 070308 with
250429 - ANC blood counts suddenly increasing, reversing an 8 month decline,
250430 - and rising to a level of safety for treatment.
250432 -  ..
250433 - Changes in emotional state are evident from vitals that increased
250434 - significantly on 070301, and have since settled back to normal, see
250435 - below. ref SDS 0 AW4L
250437 -  ..
250438 - Good news of medical progress that reduces stress, reported last week
250439 - on 070308, ref SDS E8 FO6H, is tempered by rising stress from complex
250440 - communications coordinating referral, requested by UCSF on 070301.
250441 - ref SDS E4 O67N  Examples are...
250442 -
250443 -             [On 070329 stress relieved by good medical news, and
250444 -             increases by difficulty managing communications.
250445 -             ref SDS F4 II7H
250446 -
250447 -        1.  Blood test ordered on 070308 was not scheduled. ref SDS E8
250448 -            1M6H
250450 -              ..
250451 -             [On 070322 difficulty sleeping may manifext anxiety
250452 -             managed outwardly with calm reserved demeanor. ref SDS F1
250453 -             NG4N
250455 -             ..
250456 -        2.  Coordinating schedule for CT tests case study shows stress
250457 -            rises with challenge of complex communications; people get
250458 -            mixed up, strive to expedite, cut corners on good practice,
250459 -            avoid controversy, forget, make mistakes, causing delays,
250460 -            which increase anger, fear, worry and stress, shown by case
250461 -            study on 070307, ref SDS E7 G56L, and discussed above.
250462 -            ref SDS 0 OG6G
250464 -             ..
250465 -        3.  Treatment was not scheduled today, causing stress and
250466 -            delay, per below. ref SDS 0 1M6H
250468 -             ..
250469 -        4.  Conflicts in scheduling meetings, tests, and treatments
250470 -            reported today, per below. ref SDS 0 QK6L
250471 -
250472 -
250474 -             ..
250475 -        5.  Coordination failed to distribute notice of side effects to
250476 -            prepare for discussion with the patient during a meeting at
250477 -            UCSF on 070329; people object to connecting issues in
250478 -            context that leverages the power of knowledge under the
250479 -            locality principle. ref SDS F4 945F
250481 -             ..
250482 -        6.  Meeting productivity falls, ref SDS F4 BG6K, people object
250483 -            to timely distribution of patient history for being
250484 -            prepared to work intelligently with comprehensive review of
250485 -            issues, reported 070329. ref SDS F4 W25L
250487 -  ..
250488 - Emotions swing from relief and joy getting favorable data, to sorrow,
250489 - anguish, and fear from losing support of a key medical assistant at
250490 - Kaiser for accomplishing critical details, reported on 070309.
250491 - ref SDS E9 VP73  Losing support of an able advocate for getting things
250492 - done at Kaiser, and also a friend and advisor, shown by the record on
250493 - 060809, ref SDS 98 MW3M, including recommendations to ask UCSF for 2nd
250494 - opinion consultation, ref SDS 98 3J4O, will increase difficulty
250495 - coordinating the work, shown by the study on 070307, ref SDS E7 Q65K
250496 - Obviously, loss of support, advocacy, and friendship brings a heavy
250497 - emotional cost.
250499 -  ..
250500 - Millie commented on avoiding big emotional swings.  Experience the
250501 - past 6 years shows that cancer has evolving good news and bad news
250502 - events.  Erratic changes in disease assessment from July - December
250503 - 2006, resulted in referral to UCSF, and were presented in a study on
250504 - 070130. ref SDS C7 5N6L  Exercise provides a release to help manage
250505 - stress, discussed during the meeting with the primary care physician
250506 - on 070105. ref SDS C1 MA9K
250508 -  ..
250509 - Millie is sensitive and concerned for others, but generally remains
250510 - calm and reserved, with measured reaction, i.e., stoic, encountering
250511 - complex communications that delay coordination, and frustrate
250512 - progress, per above. ref SDS 0 OR5K
250513 -
250514 -             [On 070322 difficulty sleeping may manifext anxiety
250515 -             managed outwardly with calm reserved demeanor. ref SDS F1
250516 -             NG4N
250518 -  ..
250519 - Absorbing physical and mental anguish without demonstrating emotion is
250520 - aided by a strong medical team at Kaiser and UCSF who shield many
250521 - issues by performing research, analysis, planning, and coordination.
250522 - Kaiser has avoided exposing the patient to bad news, for example on
250523 - 040504 witholding notice that the rash on the left breast was a very
250524 - serious form of cancer. ref SDS 22 WI8F  Similarly, during a meeting
250525 - on 040517 Kaiser submitted a pathology report on a biopsy that
250526 - diagnosed IBC, but there was no discussion of the report during the
250527 - meeting, and no disclosure nor explanation of IBC disease. ref SDS 23
250528 - 6T5G  The practice of witholding bad news to maintain a positive
250529 - attitude was presented earlier on 030710. ref SDS 10 IF8G  Last year,
250530 - on 060807 Millie saw a movie that someone brought to work which
250531 - explained IBC is an aggressive cancer. ref SDS 96 JR9Y  By then she
250532 - had becomne acclimated through years of treatment.  As a result, when
250533 - Millie heard on 060807 that IBC goes through the patient, like a "hot
250534 - knife through butter," the emotional charge disclosing the high risk,
250535 - aggressive character of IBC was moderated. ref SDS 96 7Q8H
250536 -
250537 -             [On 070329 stress relieved by good medical news, and rises
250538 -             with difficulty managing communications. ref SDS F4 II7H
250539 -
250540 -
250541 -
250542 -
2506 -

SUBJECTS
Tolerate Weekly Treatments Stress Constant Interruption Flexibility

3403 -
340401 -  ..
340402 - Weekly Treatments Tolerating Constant Interrutions of Life
340403 - Vacation 2 Weeks Occassional Flexibility Advance Delay Treatments
340404 - Flexibility Advance Delay Treatments 1 Day Accomodate Exigent Issues
340405 -
340406 - Brigid asked Millie about tolerating weekly treatments, as a constant
340407 - interruption to life?
340409 -  ..
340410 - Emotional tolerance is discussed above. ref SDS 0 6A7J
340412 -  ..
340413 - Discussed prospects of modifying weekly treatments to study benefits
340414 - of bi-monthly, and perhaps monthly treatments, in the event that CA
340415 - 15-3 falls below the target level of 31, and the IBC rash fully
340416 - subsides.  In that case, the disease might be controlled to the point
340417 - where weekly treatments have nothing to treat, as seemed to occur
340418 - after mastectomy surgery on 051021?
340420 -  ..
340421 - Jackie commented that the clinical study does not address this
340422 - scenario in the protocol.  At this time, the drug trial is designed
340423 - only for weekly treatments.
340425 -  ..
340426 - Jackie further seemed to indicate that there can be occassional missed
340427 - treatments, for example to take a two week vacation.  There is also
340428 - flexibility to advance or delay treatments by a day for exigent
340429 - circumstances.
340430 -
340431 -
340432 -
340433 -
340434 -
3405 -

SUBJECTS
Cetuximab Prognosis IBC May Subside for 10 Months Before Progressing

3703 -
370401 -  ..
370402 - Cetuximab Prognosis IBC May Subside for 10 Months Before Progressing
370403 - Prognosis Disease May Subside 10 Months or More Before Progression
370404 - Progresssion of Disease May be Delayed for 10 Months or More
370405 -
370406 - Millie asked about expectations for the current good news to continue?
370408 -  ..
370409 - Brigid explained that when chemotherapy treatments are changed to
370410 - recover from progression of disease, the period of favorable response
370411 - declines with each new treatment, because remaining cancer cells have
370412 - mutated into more aggressive disease.  Since Millie is recovering from
370413 - the 3rd relapse of IBC, she is high risk of early treatment failure.
370414 - The primary care physician discussed the cancer mutation challenge on
370415 - 030710. ref SDS 10 FZ55  Cetuximab is Millie's 4th overall therapy
370416 - regimen, reported on 061230. ref SDS C0 PN5X
370418 -  ..
370419 - Brigid further commented that, since Millie is just starting the
370420 - Cetuximab treatment, the time to progression of disease is hard to
370421 - predict.
370422 -
370423 -     [On 080313 case study shows Millie suffers 4th relapse of IBC,
370424 -     ref SDS F8 0T8H; Carboplatin added to the treatmnt regimen because
370425 -     IBC disease progressed, ref SDS F9 TZ8I, diagnosed the week before
370426 -     on 080306. ref SDS F8 NW3N
370428 -  ..
370429 - Brigid cited an 80 year old woman who has been treated in the clinical
370430 - study with cetuximab and carboplatin for over 10 months without
370431 - progression of disease.  This seems to be the best response achieved
370432 - in the study so far at UCSF.
370433 -
370434 -     [On 070510 treatment for the 80 year old patient was changed to
370435 -     Gemzar because cancer began to progress. ref SDS F7 5P8J
370436 -
370437 -
370438 -
3705 -

SUBJECTS
Measureable Disease IBC Rash Tape Measure Evaluate Progression of Di

4003 -
400401 -  ..
400402 - Measureable Disease Photographs IBC Rash Improving
400403 - IBC Rash Improved Measurable Disease Photographs Tape Measure
400404 -
400405 - Follow up ref SDS E8 6T6M, ref SDS E5 6T6M.
400406 -
400407 - Brigid took measurements of IBC rash.  Since the disease spreads
400408 - randomly at each location, dimensions are arbitrary.  Brigid commented
400409 - that measurements seem unchanged, but intensity has declined, per
400410 - above. ref SDS 0 FO6H
400412 -  ..
400413 - CA 15-3 dropping to 36 is the most significant measure of response to
400414 - cetuximab treatment at this time.
400415 -
400416 -
400417 -
400418 -
400419 -
4005 -

SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A

4503 -
450401 -  ..
450402 - Side Effects Medicated After Weekly Examinations
450403 -
450404 - Follow up ref SDS E8 FO66, ref SDS E5 FO66.
450405 -
450406 - Brigid was pleased that treatment prescribed on 070222, ref SDS E1
450407 - FO66, seems effective minimizing acne-like rash in Millie's case.  She
450408 - described severe breakout experienced by other patients, which so far
450409 - has not occurred to Millie.
450411 -  ..
450412 - Millie reported that Curel lotion prescribed by Brigid on 070301 has
450413 - helped relieve facial dryness, ref SDS E4 5V73, reported previously
450414 - last week on 070308, ref SDS E8 JS6M, and discussed again with Diane
450415 - in the Infusion Clinic prior to treatment today, per below.
450416 - ref SDS 0 JS6M
450417 -
450418 -        [On 070322 dry skin problem expands from face to chest and
450419 -        arms; UCSF pharmacy recommends aquaphor to supplement Curel
450420 -        lotion. ref SDS F1 JS6M
450422 -         ..
450423 -        [On 070329 Millie looks great, and feels fortunate to have
450424 -        avoided severe skin rash side effects of cetuximab by applying
450425 -        treatment prescribed by Brigid. ref SDS F4 N49K
450427 -  ..
450428 - Brigid asked about fatigue, shortness of breath, energy?
450430 -  ..
450431 - Millie explained her energy remains elevated compared to previous
450432 - treatment with Taxotere and capecitabine.  She thought there was a
450433 - decline during the week on 070301, but the past few weeks her energy
450434 - has rebounded, as reported last week on 070308. ref SDS E8 CA4K  This
450435 - has been a significant improvement in qualify of life, discussed with
450436 - Doctor Rugo on 070301. ref SDS E4 TQ6L
450438 -  ..
450439 - Side effects were reviewed again during treatment today in the
450440 - Infusion Clinic. ref SDS 0 QU8K
450442 -  ..
450443 - After treatment today, a new side effect of benadryl was reported,
450444 - generally described as "restless legs." ref SDS 0 F77K
450445 -
450446 -
450447 -
450448 -
450449 -
4505 -

SUBJECTS
Blood Tests Cetuximab Monthly Clinical Study Drug Trial Performed at

4803 -
480401 -  ..
480402 - Blood Tests 1 Per Month on Cetuximab Performed at UCSF Saves Time Cost
480403 -
480404 - Follow up ref SDS E8 XR40, ref SDS E5 XR40.
480405 -
480406 - The next blood test is scheduled for 070329 to start cycle #3.
480408 -  ..
480409 - Actually, the schedule does not show times for blood draws, and so may
480410 - require further coordination, shown below. ref SDS 0 QK6L
480411 -
480412 -
480414 -  ..
480415 - INR 2.5 Low Pulmonary Embolism Needs Increase Coumadin Treatment
480416 - Pulmonary Embolism Treatment Coumadin Needs Increase Low INR 2.5
480417 -
480418 - Follow up ref SDS E8 6U5J, ref SDS E5 6U5J.
480419 -
480420 -
480421 -
480422 -
480423 -
480424 -
4805 -

SUBJECTS
Cetuximab 2nd Cycle 3rd Treatment 7th Total Treatment Chemotherapy 9

6503 -
6504 - 0845
650501 -  ..
650502 - Infusion Clinic for Cetuximab Treatment
650503 -
650504 - Follow up ref SDS E8 1M6H, ref SDS E5 1M6H.
650505 -
650506 - The receptionist, Nola, said that Millie is not scheduled for
650507 - treatment today, similar to last week, when the blood test had not
650508 - been scheduled. ref SDS E8 1M6H  Coordination issues were reviewed in
650509 - a study on 070130. ref SDS C7 4T5N  Coordination planning was
650510 - discussed at UCSF on 070301. ref SDS E4 RM4G  Scheduling treatments
650511 - and blood tests were cited as examples of coordination by UCSF staff.
650512 - ref SDS E4 PR4L
650514 -  ..
650515 - Millie asked if she is supposed to just go home?  Millie asked Nola to
650516 - check with Catherine who knows patient history of weekly treatments.
650517 - Nola said that Catherine is out today, so nobody is available in the
650518 - clinic who is familiar with patient history.
650520 -  ..
650521 - Nola asked about Millie's treatment protocol and the name of the
650522 - doctor?
650524 -  ..
650525 - The cetuximab clinical study calls for weekly treatments, and these
650526 - have been scheduled for Thursday mornings, beginning on 070201.
650527 - ref SDS C9 4W49  Millie explained having met with Brigid and Jackie
650528 - earlier this morning, who work with Doctor Rugo.  They seemed to
650529 - expect that Millie is supposed to get treatment today, see above.
650530 - ref SDS 0 9R9M and ref SDS 0 6A4J  There was no discussion that Doctor
650531 - Rugo cancelled treatment.  That was supposed to be considered last
650532 - week, but diagnostics were favorable, and so the understanding was
650533 - that weekly treatments were to continue. ref SDS E8 FO6H
650535 -  ..
650536 - Nola said that patients treated by the Infusion Clinic are normally
650537 - scheduled by their doctor, and the pharmacy is notified to prepare
650538 - drugs.  There is nothing in Millie's file showing treatments have been
650539 - scheduled for today nor for the future.
650541 -  ..
650542 - Nola asked how long Millie will be getting treatments?
650544 -  ..
650545 - Millie explained that duration of treatment is determined by the
650546 - doctor.  This was discussed with Brigid earlier today, and the
650547 - indication is that treatment will continue indefinitely, per above.
650548 - ref SDS 0 6A9H
650550 -  ..
650551 - Nola went ahead and scheduled Millie for treatments the next few
650552 - months, shown below. ref SDS 0 159O  She will coordinate with the
650553 - doctor on scheduling procedures for the Infusion Clinic.  Nola will
650554 - coordinate with Millie's nurse on notifying the pharmacy to prepare
650555 - drugs for treatment today in accordance with the cetuximab protocol,
650556 - per below. ref SDS 0 IJ41  She explained that delayed notice on
650557 - preparing drugs will delay Millie's treatment about 40 minutes or so.
650559 -  ..
650560 - Millie thanked Nola for taking immediate action to provide exigent
650561 - scheduling and coordination.
650563 -  ..
650564 - Catherine is out today.  Diane is the replacement nurse.
650566 -  ..
650567 - Later, after treatment was completed, Millie said things went better
650568 - today than occurred last week. ref SDS E8 QG7K  Diane asked about side
650569 - effects today, as a cross-check on Brigid's review, per below,
650570 - ref SDS 0 QU8K  Diane, also, checked the protocol today, and followed
650571 - requirements to perform 3 sets of vitals. ref SDS 0 AW4L  She was
650572 - further aware that Millie requires a 1 hour rest period after
650573 - treatment. ref SDS 0 H34H
650575 -  ..
650576 - Millie was not disturbed today by people in adjacent chairs.  She was
650577 - in a larger room, and because treatment started early, there were only
650578 - a few other patients.  All were respectful of each other in avoiding
650579 - excessive loud chatter, which was a problem last week. ref SDS E8 QG8I
650580 -
650581 -
650582 -
650583 -
650585 -  ..
6506 -
6507 -
6508 - 1033
6509 -
650901 - Millie received 7th overall and 3rd treatment of 2nd cycle with
650902 - Cetuximab, starting from 070201, ref SDS C9 G68I, and the 14th
650903 - treatment for 3rd relapse of IBC, beginning on 060721. ref SDS 90 407N
650905 -           ..
650906 -          Taxotere Capecitabine Started 060721 Ended 061201
650907 -
650908 -          Follow up ref SDS E8 PR8Q, ref SDS E5 PR8Q.
650909 -
650910 -                   Relapse Treatments
650911 -
650912 -      1.  Cycle 09 and 01 ................... 060721, ref SDS 90 407N
650913 -      2.  Cycle 10 and 02 ................... 060814, ref SDS A0 LY6O
650914 -      3.  Cycle 11 and 03 ................... 060908, ref SDS A3 407N
650915 -      4.  Cycle 12 and 04 ................... 060929, ref SDS A5 407N
650916 -      5.  Cycle 13 and 05 ................... 061020, ref SDS B0 407N
650917 -      6.  Cycle 14 and 06 ................... 061110, ref SDS B4 407N
650918 -      7.  Cycle 15 and 07 ................... 061201, ref SDS B6 407N
650920 -           ..
650921 -          Cetuxiab Clinical Study Started 070201
650922 -
650923 -          Follow up ref SDS E8 7T3H, ref SDS E5 7T3H.
650924 -
650925 -                   Total    Cetuximab
650926 -      8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS C9 SG8I
650927 -      9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS D2 SG8I
650928 -     10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS D6 SG8I
650929 -     11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS E2 SG8I
650930 -     12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS E5 SG8I
650931 -     13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS E8 SG8I
650932 -     14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 0 SG8I
650934 -  ..
650935 - Nurses Notes...
650946 -     ..
650947 -    UCSF Log Time...
650948 -
650949 -                   Blood
650950 -                    Test   Infusion
650951 -
650952 -          In.......          0845
650953 -          Out......          1245
650954 -          Visit....      Min  4.0  Hours
650956 -      ..
650957 -     Pain Assessment...
650958 -
650959 -          x
650960 -          0123456789 10
650961 -
650962 -     <923k
650963 -     Administration Site:  Right Port Catheter
650964 -     Needle Size:          20 G 1"
650965 -     Blood Return Good:    Yes
650967 -      ..
650968 -     Remind patient to call MD if temp > 101 F, Shaking Chills
650969 -
650970 -            This protocol differs from Kaiser requirements, reported on
650971 -            041202. ref SDS 50 IX9N
650972 -
650973 -
650974 -
650975 -
6510 -

SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A

7603 -
7604 - 0910
760501 -  ..
760502 - Side Effects Consultation Pharmacist Heavy Chest Difficult Breathing
760503 -
760504 - Follow up ref SDS E8 QU8K, ref SDS E5 QU8K.
760506 -  ..
760507 - Millie was asked about side effects today, per above. ref SDS E8 QG7K
760508 -
760509 -            Rash like acne
760510 -
760511 -               Mild condition continues from 070208 around the nose,
760512 -               ref SDS D2 QU8K; treatment effective with medication
760513 -               prescribed on 070222. ref SDS E2 FO66
760515 -             ..
760516 -            Face very dry...
760517 -
760518 -               Millie notified UCSF in a letter on 070228 of sudden
760519 -               extremely dry face, a new side effect of cetuximab.
760520 -               ref SDS E3 LR4S  The next day, on 070301, Brigid
760521 -               prescribed Curel lotion. ref SDS E4 5V73  Since that
760522 -               time, treatment with Curel has brought some relief, per
760523 -               examination by Brigid prior to treatment, set out above.
760524 -               ref SDS 0 6B8H
760526 -             ..
760527 -            Rash on right chest
760528 -
760529 -               Nurse's Progress Notes report rash on upper right chest
760530 -               (the area observed during connection of the IV to the
760531 -               port catheter), and that Millie commented this occurred
760532 -               before starting treatment with cetuximab.  Millie does
760533 -               not recall this discussion.  There is no evident
760534 -               continuing rash on the upper right chest, as there is on
760535 -               the left breast area.  The nurse may have gotten mixed
760536 -               up between the time of the discussion with Millie and
760537 -               minutes or hours later when the notes were prepared.  At
760538 -               this time, there is clear IBC like rash on a small part
760539 -               of the right breast that is continuous with the rash on
760540 -               the left chest, reported on 061204, ref SDS B8 AE5I; at
760541 -               that time the doctor was notified of this new condition.
760542 -               ref SDS B8 V45L  This area was not visible during
760543 -               treatment today.
760544 -
760545 -                   [On 070322 examination during treatment observes
760546 -                   various skin blemishes that are not identified as
760547 -                   "rash." ref SDS F1 KU3L
760549 -                    ..
760550 -                   [On 070329 Nurse's Notes again do not report a rash
760551 -                   above the port on the right side. ref SDS F5 KU3L
760553 -                    ..
760554 -                   [On 070330 examination at Kaiser by primary care
760555 -                   physician finds significantly increased intensity of
760556 -                   rash on upper left arm, ref SDS F6 N19J, and a
760557 -                   similar new rash above the right breast and below
760558 -                   the colar bone, ref SDS F6 583G; these dramatic
760559 -                   changes in condition were diagnosed without biopsy
760560 -                   as complications of lymphedema causing Cellulitis
760561 -                   with elevated temperature, and possibly triggered by
760562 -                   patient's increased exercise that overtaxed the
760563 -                   system. ref SDS F6 7C7F  Keflex antibiotics was
760564 -                   prescribed, ref SDS F6 474O; about 3 hours later
760565 -                   self-examination showed these erruptive rash
760566 -                   conditions had subsided, and so Keflex treatment was
760567 -                   not performed. ref SDS F6 KZ6L
760569 -             ..
760570 -            Restless legs
760571 -
760572 -               Millie discussed today after treatment a growing issue
760573 -               of restless anxiety that drives desire to move, get up
760574 -               from the infusion chair, and walk around, following
760575 -               treatment with Benadryl, per below. ref SDS 0 GC5G  This
760576 -               has not been previusly presented, and was not discussed
760577 -               with the nurse today
760578 -
760579 -                   [On 070322 Benadryl pre-treatment medication slowed
760580 -                   from 10 to 15 minutes; relieved some of the problem.
760581 -                   ref SDS F1 F77K
760583 -                    ..
760584 -                   [On 070329 "restless legs" problem with Benadryl
760585 -                   resolved with Brigid's change in treatment dose.
760586 -                   ref SDS F5 F77K
760588 -             ..
760589 -            Lymphedema Cellulitis Complications
760590 -
760591 -               Lymphedema continues relatively controlled.  There is no
760592 -               association with cetuximab treatments, since the
760593 -               proximate cause was left breast mastectomy with removal
760594 -               of lymph nodes in the left axillar, and is complicated
760595 -               by exercise to strengthen the immune system for
760596 -               resisting cancer, and by cat bites that flow from
760597 -               engaging pets for qualify of life, reported in the case
760598 -               study on 070130. ref SDS C7 VX6F
760599 -
760601 -             ..
760602 -            Tired, fatigued - pulmonary emoblism...
760603 -
760604 -               Fatigue, shortness of breath and other symptoms of
760605 -               pulmonary embolism were presented during meeting on
760606 -               070130, ref SDS C7 CV5L, citing case study listed on
760607 -               060722. ref SDS 91 ZV41
760609 -                ..
760610 -               On 070218 Millie notified the primary care physician and
760611 -               UCSF that energy continues to recover; she played tennis
760612 -               and pulse reached 144. ref SDS E0 N05H
760614 -                ..
760615 -               Energy that seemed to be declining leading up to
760616 -               treatment on 070301, ref SDS E5 CA4K, seems to be still
760617 -               rising back to normal, continuning improvement reported
760618 -               last week on 070308. ref SDS E8 CA4K
760619 -
760621 -             ..
760622 -            Heavy chest - shortness of breathing
760623 -
760624 -               Patient history was reported to UCSF on 070130.
760625 -               ref SDS C7 RT6I
760626 -
760627 -               Condition seems improved, as reported on 070204.
760628 -               ref SDS D1 JJ7O  No noticable increase, aligns with
760629 -               continuing higher energy. ref SDS E8 CA4K
760630 -
760632 -             ..
760633 -            Cough - clearing throat
760634 -
760635 -               This condition seems improved, as reported to the doctor
760636 -               on 070130. ref SDS C7 RT6I
760637 -
760639 -             ..
760640 -            Dry hands and feet...
760641 -
760642 -               Dry hands and feet seem much improved since ending
760643 -               treatment with Taxotere and capecitiabine on 061201.
760644 -
760646 -             ..
760647 -            Eyes tearing
760648 -
760649 -               This seems improved since ending treatment with Taxoter
760650 -               and capecitabine on 061201.
760651 -
760653 -             ..
760654 -            Nausea and vomitting
760655 -
760656 -               Problems with Taxotere and capecitabine reported on
760657 -               061110, ref SDS B4 D19M, did not occur this past week
760658 -               after treatment with cetuximab.  As a result, there was
760659 -               no pre-treatment with Decadron today, per below.
760660 -               ref SDS 0 G57I
760662 -             ..
760663 -            Sores in mouth
760664 -
760665 -               None yet, cleaning mouth carefully to avoid problem.
760666 -
760667 -
760668 -
760669 -
7607 -

SUBJECTS
Schedule Treatment Weekly Thursday 0800 4 Week Cycles Clinical Study

8003 -
800401 -  ..
800402 - Schedule Weekly Treatments Continue on Thursdays
800403 -
800404 - Follow up ref SDS E8 QK6L, ref SDS E5 QK6L.
800406 -  ..
800407 - Schedule for monthly meetings with Doctor Rugo, Brigid, and Jackie,
800408 - per above, ref SDS 0 MQ3M, and for weekly treatments, was submitted by
800409 - Nola, per above, ref SDS 0 E29H
800410 -
800411 -            [On 070510 UCSF submitted updated schedule of meetings and
800412 -            treatments. ref SDS F7 CQ4I
800414 -  ..
800415 - As noted, this schedule may need review to include blood draws on days
800416 - when new treatment cycles start, ref SDS 0 XR40, and Millie meets with
800417 - Doctor Rugo.  The plan Jackie and Catherine developed on 070201 was
800418 - for Millie to get blood drawn an hour prior to meeting with the
800419 - doctor, so the analyst has time to post the pathology report, which
800420 - the doctor needs to support the examination, as called out by the
800421 - clinical study protocol. ref SDS C9 XR40
800423 -     ..
800424 -    Date  Time  Staff      Sta Type Dept  Loc  Dur  Number    Cycl/Trea
800425 -    -----------------------------------------------------------------
800426 -    070322 0900  Catherine    APR  P1H  CCINF  INF  60  12763480 02 04
800427 -    070329 0800  Doctor Rugo  PEN  CHF  BCC    Z4F  30  12762558 03 01
800428 -                 Brigid,
800429 -                 Jackie
800430 - *  070329 0845  Catherine    PEN  P1H  CCINF  INF  60  12763486 03 01
800431 -
800432 -            [On 070326 letter to Jackie on coordinating meetings and
800433 -            treatment with blood draws. ref SDS F2 407N
800435 -             ..
800436 -            [On 070326 called the UCSF Infusion Clinic; they indicate
800437 -            Millie can get blood drawn on 070329 OB 0800. ref SDS F2
800438 -            KL30
800440 -     ..
800441 -    070405 0830  Catherine    PEN  P1H  CCINF  INF  60  12763636 03 02
800442 -    070412 0830  Brigid       PEN  CHF  BCC    Z4F  30  12762673 03 03
800443 -                 Jackie
800444 -    070412 0830  Catherine    PEN  P1H  CCINF  INF  60  12763644 03 03
800445 -    070419 0830  Catherine    PEN  P1H  CCINF  INF  60  12763651 03 04
800446 - *  070426 0800  Doctor Rugo  PEN  CHF  BCC    Z4F  30  12762597 04 01
800447 -                 Brigid,
800448 -                 Jackie
800449 -    070426 0830  Catherine    PEN  P1H  CCINF  INF  60  12763658 04 01
800450 -     ..
800451 -    070503 0830  Catherine    PEN  P1H  CCINF  INF  60  12764302 04 02
800452 -    070510 0800  Brigid       PEN  CHF  BCC    Z4F  30  12762609 04 03
800453 -                 Jackie
800454 -    070510 0830  Catherine    PEN  P1H  CCINF  INF  60  12764309 04 03
800455 -    070517 0830  Catherine    PEN  P1H  CCINF  INF  60  12764317 04 04
800456 - *  070524 0830  Doctor Rugo  PEN  CHF  BCC    Z4F  30  12762615 05 01
800457 -                 Brigid,
800458 -                 Jackie
800459 -    070524 0830  Catherine    PEN  P1H  CCINF  INF  60  12764323 05 01
800460 -
800461 -            [On 070510 UCSF submitted updated schedule of meetings and
800462 -            treatments. ref SDS F7 CQ4I
800464 -  ..
800465 - Scheduling issues include...
800466 -
800467 - *      1.  Blood tests required for monthly meetings so that results
800468 -            are available to the doctor in time for examination prior
800469 -            to starting the next treatment cycle.  This generally
800470 -            requires getting a blood test about an hour before the
800471 -            meeting, so there is time for processing by the laboratory
800472 -            and posting results to the computer.  Another problem is
800473 -            transmitting test results to Kaiser, including INR tests
800474 -            that guide Coumadin treatments for pulmomary embolism.
800475 -            This has been very difficult so far.
800476 -
800477 -                [On 070326 letter to Jackie on coordinating meetings
800478 -                and treatment with blood draws. ref SDS F2 407N
800480 -                 ..
800481 -                [On 070326 called the UCSF Infusion Clinic; they
800482 -                indicate Millie can get blood drawn on 070329 OB 0800.
800483 -                ref SDS E1 KL30
800485 -                 ..
800486 -                [On 070327 Jackie called and confirmed she ordered the
800487 -                blood test for 070329 0800. ref SDS F3 5V6J
800489 -                 ..
800490 -                [On 070329 0800 blood test performed at UCSF.
800491 -                ref SDS F5 Q659
800493 -             ..
800494 -        2.  Kaiser a block away from UCSF opens for patients to get
800495 -            blood tests OA 0630.  This fits the hour processing time
800496 -            for meeting with Doctor Rugo at 0800, however, there could
800497 -            be a problem getting the data transmitted from Kaiser,
800498 -            illustrted by the record on 070307. ref SDS E7 Q65K  Blood
800499 -            tests at Kaiser would avoid prior problems coordinating to
800500 -            get INR results to Gloria at the Kaiser Coagulation Control
800501 -            Clinic in Martinez, CA, since the data would be presented
800502 -            to Gloria through Kaiser's computer system, which makes
800503 -            Gloria's work fast and easy, to avoid mistakes, reported on
800504 -            070307. ref SDS E7 UA3L
800506 -             ..
800507 -            UCSF lab may also be open to draw blood at 0630.  There is
800508 -            a big advantage having blood drawn at UCSF, because the
800509 -            data will be posted to the UCSF computer, so there will not
800510 -            be a traumatic coordination problem to obtain data from
800511 -            Kaiser, nor require transcribing data, which causes errors,
800512 -            and further will not require transforming Kaiser test units
800513 -            and standards into UCSF criteria, which is much different,
800514 -            reported on 070301. ref SDS E5 8W46
800516 -             ..
800517 -            In both cases, blood draws in the lab cannot use the port
800518 -            to minimize trauma to Millie's arm.
800520 -             ..
800521 -        3.  If the schedule for meeting with Doctor Rugo, Brigid, and
800522 -            Jackie is changed on 070329 from 0800 to later in the day,
800523 -            this would disrupt the treatment schedule.  Presumably,
800524 -            they are now fully booked.
800526 -             ..
800527 -            Millie could go out to UCSF the day before during lunch, or
800528 -            after work to have blood drawn for the test.  This should
800529 -            make results available in time for meeting with the doctor
800530 -            at 0800 on 070329.  Getting on the bus, or taking a cab to
800531 -            UCSF, and then getting back to Embarcadero 2 to contiue
800532 -            work, or take BART home will be a big inconvenience, but
800533 -            may be the only solution.
800535 -             ..
800536 -        4.  Maybe people get to work early in the Infusion Clinic, and
800537 -            can draw blood for processing the Lab in time for meeting
800538 -            with Doctor Rugo at 0800.
800539 -
800540 -                [On 070326 called the UCSF Infusion Clinic; they
800541 -                indicate Millie can get blood drawn on 070329 OB 0800.
800542 -                ref SDS E1 KL30
800544 -                 ..
800545 -                [On 070327 Jackie called and confirmed she ordered the
800546 -                blood test for 070329 0800. ref SDS F3 5V6J
800548 -                 ..
800549 -                [On 070329 0800 blood test performed at UCSF.
800550 -                ref SDS F5 Q659
800551 -
800552 -
800553 -
800554 -
800555 -
800556 -
800557 -
800558 -
800559 -
800560 -
800561 -
8006 -

SUBJECTS
Blood Counts ANC Normal 1.51 Test 070308 Safe for Cetuximab 2nd Trea

8303 -
8304 - 0840
830501 -  ..
830502 - Blood Counts Normal Full Dose Cetuximab Ordered
830503 - Blood Test Not Scheduled Infusion Clinic Took Approprite Action
830504 -
830505 - Follow up ref SDS E8 Q659, ref SDS E5 Q659.
830506 -
830507 - The next blood test is scheduled for 070329.
830508 -
830509 -
830510 -
830511 -
830512 -
830513 -
8306 -

SUBJECTS
Coagulation Control Coumadin Treatment Pulmonary Embolism INR 2.5 PT

9003 -
900401 -  ..
900402 - Coagulation Control INR High 2.5 PT 28 High
900403 -
900404 - Follow up ref SDS E8 SE6N, ref SDS E5 SE6N.
900405 -
900406 - Next blood test for INR is on 070329, per planning on 070308.
900407 - ref SDS E8 CS6J
900408 -
900409 -
900410 -
900411 -
9005 -

SUBJECTS
Absolute Neutrophils Count ANC 1510 Below 1800 UCSF Criteria But Abo

A403 -
A40401 -  ..
A40402 - ANC 1510 Below 1800 Criteria for Blood Counts to Approve Treatment
A40403 -
A40404 - Follow up ref SDS E8 P560, ref SDS E5 P560.
A40405 -
A40406 - The next blood test is scheduled for 070329.
A40407 -
A40408 -
A40409 -
A40410 -
A405 -

SUBJECTS
Blood Tests CA 15-3 36 Test 070301 Results Submitted by UCSF CA 15-3

A903 -
A90401 -  ..
A90402 - CA 15-3 36 Tests 2 From Kaiser 1 from UCSF Pending Submission
A90403 -
A90404 - Follow up ref SDS E8 2N5J, ref SDS E5 2N5J.
A90405 -
A90406 - The next blood test is scheduled for 070329.
A90407 -
A90408 -
A90409 -
A905 -

SUBJECTS
Port Catheter IV Connection Prepare for Drip Treatment 1 Try Require

AD03 -
AD04 - 1045
AD0501 -  ..
AD0502 - Preparation for Treatment Required One (1) Attempt to Connect Port
AD0503 -
AD0504 - Follow up ref SDS E8 EB7J, ref SDS E5 EB7J.
AD0506 -  ..
AD0507 - The nurse connected the IV tubes to the port....
AD0509 -       ..
AD0510 -      Interlink System Vented Paclitaxel set
AD0512 -  ..
AD0513 - Like last week and earlier on 070301, there were no problems getting
AD0514 - blood to flow from the port, ref SDS E5 EB7J, as occurred on 070222,
AD0515 - ref SDS E1 DC5W, and earlier on 070201. ref SDS C9 DC5W
AD0517 -  ..
AD0518 - The nurse flushed the port with saline.
AD0519 -
AD0520 -
AD0521 -
AD0522 -
AD06 -

SUBJECTS
Blood Draws 7 Vials Clinical Study Research Cetuximab Drug Trial Blo

AH03 -
AH0401 -  ..
AH0402 - Blood Draws 7 Vials for Clinical Study Research
AH0403 -
AH0404 - Follow up ref SDS E8 O56V, ref SDS E5 O56V.
AH0405 -
AH0406 - There were no blood draws today, because the study requires blood for
AH0407 - research only at the beginning of each cycle, and this is the 2nd
AH0408 - treatment in the 2nd cycle.
AH0409 -
AH0410 -
AH0411 -
AH0412 -
AH0413 -
AH05 -

SUBJECTS
Benadryl Pre-treatment Prepares Patient for Cetuximab Chemotherapy A

AK03 -
AK04 - 0945
AK0501 -  ..
AK0502 - Benedryl Reduce Side Effects Cetuximab Chemotherapy Treatment
AK0503 -
AK0504 - Follow up ref SDS E8 DC7J, ref SDS E5 DC7J.
AK0505 -
AK0506 - Benadryl (diphenhydramine) started.   50 MG....... ref SDS 0 IJ41
AK0507 -
AK0508 -        Purpose reported on 060721. ref SDS 90 DC7J
AK0510 -  ..
AK0511 - Chemotherpay order calls for Benadryl (diphenhydramine) pre-treatment
AK0512 - 30 - 60 minutes prior to cetuximab infusion, shown below. ref SDS 0
AK0513 - IJ41
AK0515 -  ..
AK0516 - Millie has been experiencing "restless legs," associated with Benedryl
AK0517 - treatments.  There is an axious feeling that makes sitting and
AK0518 - resting, which is one purpose of Benedryl, difficult.  There is an
AK0519 - unpleasant feeling that is relieved by getting up and moving, walking
AK0520 - around.
AK0521 -
AK0522 -
AK0524 -  ..
AK06 -
AK07 -
AK08 - 0955
AK09 -
AK0901 - Benadryl completed equipment beeps.
AK0902 -
AK0903 -
AK0905 -  ..
AK10 -
AK11 -
AK12 -
AK13 -
AK1301 - Decadron IV treatment started -- not reported
AK1302 -
AK1303 - On 070208 Decadron was not given because Millie did not experience
AK1304 - side effects of nausea and vomitting after treatment with cetuximab on
AK1305 - 070201. ref SDS D3 G57I  Since this favorable condition continues, per
AK1306 - above, ref SDS 0 D19M, Decadron was not given again today.
AK1307 -
AK1308 -
AK1309 -
AK1310 -
AK1312 -  ..
AK14 -
AK15 -
AK16 -
AK17 -
AK1701 - Decadron completed -- not reported.
AK1702 -
AK1703 -
AK1704 -
AK1705 -
AK18 -

SUBJECTS
Cetuximab 2nd Cycle 3rd Treatment Clinical Study Drug Trial Treatmen

AM03 -
AM04 - 1040
AM0501 -  ..
AM0502 - Cetuximab Full Dose Blood Counts on Targets Treatment 1 Hour
AM0503 -
AM0504 - Follow up ref SDS E8 4N5M, ref SDS E5 4N5M.
AM0505 -
AM0506 - Since there was no treatment scheduled today, per discussion with
AM0507 - Nola, above, ref SDS 0 1M6H, there was a delay of about an hour while
AM0508 - the pharmacy was notified and prepared cetuximab treatment for
AM0509 - Millie.
AM0511 -  ..
AM0512 - Cetuximab started.
AM0513 -
AM0514 -           Verify chemotherapy order for 070208.
AM0516 -  ..
AM0517 - Chemotherapy Orders...
AM0518 -
AM0524 -    Auth#                                     Stor BCC LOC
AM0525 -    Visit:  12575738             DOS 20070201
AM0527 -     ..
AM0528 -    Date:  20070201
AM0530 -     ..
AM0531 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
AM0532 -    in combination with Carboplatin in ER-negative, PR-negative,
AM0533 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers
AM0535 -     ..
AM0536 -    Dates to be given:  070201
AM0537 -    Arm 1:Cetuximab alone
AM0539 -     ..
AM0540 -    Diagnosis:  breast cancer
AM0542 -     ..
AM0543 -    ICD-9 codes: 174.9
AM0544 -    Allergies  NKDA
AM0546 -     ..
AM0547 -    Pre-medications 30 - 60 minutes prior to cetuximab infusion
AM0549 -     ..
AM0550 -    6. Diphenhydramine 50 mg IV or  [illegible writing]
AM0552 -     ..
AM0553 -    7. Dexamethasone (??) 10 mg IB or 20 mg IV [handwritten ???]
AM0554 -
AM0555 -       Further premed TBD [barely legible handwriting??]
AM0557 -     ..
AM0558 -    Medication:  (plan to give weekly ********STUDY SUPPLY**********
AM0560 -     ..
AM0561 -    8. Cetuximab (Erbitux) (loading dose)
AM0562 -
AM0563 -              400 mg/m [squared] = 684 mg IV over 120 minutes for
AM0564 -              first dose x 1
AM0565 -
AM0566 -       dose on dcte 20070201   Maximum infusion rate is 5 ml/minute
AM0567 -       (concentration 2 mg/ml)
AM0569 -     ..
AM0570 -    9. Cetuximab (Erbitux) (maintenance dose)
AM0571 -
AM0572 -              250 mg/m [squared] = 428 mg IV (or ____ mg/m[squared] =
AM0573 -              ____mg) IV over 60 or ____ minutes.
AM0574 -
AM0575 -       Maximum infusion rate is 5 ml/minute (concentration 2 mg/ml)
AM0576 -       Infuse once weekly for 8 weeks.  First dose to be given on date
AM0577 -       20070201.
AM0579 -        ..
AM0580 -       Cetuximab is administered undiluted through a low protien
AM0581 -       binding 0.22 micro in-line filter.  Use NS solution to flush the
AM0582 -       line at the end of the infusion.
AM0584 -        ..
AM0585 -       ARM 2:  Administer carboplatin of vital signs are unremarkable
AM0586 -       one hour after cetuximab infusion.
AM0588 -        ..
AM0589 -       Vital signs at baseline, upon cetuximab completion and one hour
AM0590 -       after cetuximab.
AM0591 -
AM0592 -       ****please note start and stop times****
AM0594 -        ..
AM0595 -       Laboratory work:
AM0596 -
AM0597 -          See carboplatin orders
AM0599 -        ..
AM0600 -       x  Notify MD for dose modifications if patient has severe
AM0601 -          acne in form rash
AM0602 -
AM0603 -          CBC with differential and platletes every 4 weeks
AM0604 -          Creatinine and magnesium every 4 weeks
AM0605 -          BUN AST Alk phos Alt Total bilrubin, electrolyes every 8
AM0606 -          weeks.  If levels are outside of normal laboratory values
AM0607 -          notify Brigid NP  (MD/RN) at 415 443 4730
AM0609 -        ..
AM0610 -       x  Physician has discussed risks/benefits of therapy with the
AM0611 -          patient.  Signed consent obtained.
AM0612 -
AM0613 -
AM0614 -          Yes  No   O2 by nasal cannula at 2 liters/min prn for chest
AM0615 -          pain or SOB
AM0617 -           ..
AM0618 -          Yes  No   Diphenhydramine 50 mg IV prn x1 for urticaria
AM0619 -          [barely legible], pruritis SOB
AM0621 -           ..
AM0622 -          Yes  No   Hydrocortizone 100 mg IV prn x1 for urticaria
AM0623 -          [barely legible], pruritis SOB
AM0625 -           ..
AM0626 -          Yes  No   Albuterol inhaler 2-4 puffs prn SOB or chest
AM0627 -          tightness
AM0629 -           ..
AM0630 -          Yes  No   Epinephrine 1x1000 (1 mg/ml) 0.3 mg IV prn
AM0631 -          anaphylaxis
AM0633 -           ..
AM0634 -          Breast CC05752 Cetuximab doc 20061024
AM0635 -          Approved 20060615
AM0637 -           ..
AM0638 -          Physician signature [Hope Rugo]
AM0640 -           ..
AM0641 -          Provider#  35313
AM0643 -           ..
AM0644 -          Date:  20010131
AM0645 -
AM0647 -  ..
AM07 -
AM08 -
AM09 - 1140
AM10 -
AM1001 - Cetuximab treatment completed.
AM1002 -
AM1003 - Millie had a 1 hour rest and observation period, required by the
AM1004 - protocol. ref SDS 0 G679
AM1005 -
AM1006 -
AM1007 -
AM1009 -  ..
AM11 -
AM12 -
AM13 - 1240
AM14 -
AM1401 - The nurse disconnected the IV tubes.
AM1403 -  ..
AM1404 - She inserted Herceptin to flush the port.
AM1406 -  ..
AM1407 - She then removed the needle from the port, and swabbed the needle
AM1408 - wound, and placed a temporary bandage.
AM1409 -
AM1410 -
AM1411 -
AM1412 -
AM1413 -
AM15 -

SUBJECTS
Vitals Blood Pressure Pulse Temperature Sa02 Weight Infusion Treatme

AP03 -
AP04 - 0945
AP0501 -  ..
AP0502 - Vitals Show Patient Stable
AP0503 -
AP0504 - Follow up ref SDS E8 AW4L, ref SDS E5 AW4L.
AP0505 -
AP0506 -                    Blood
AP0507 -    Date   Time     Pressure   Pulse  Temprtr  Weight   So2
AP0509 -     ..
AP0510 -    070315 1300..... 119  75     58     36.2c            98
AP0511 -    070315 1150..... 137  73     52     36.5c            99
AP0512 -    070315 0945..... 143  85     60     36.4c            97
AP0513 -    070308 1100..... 144  87     70     36.0c            98
AP0514 -    070301 1645..... 125  62     90 *   36.4c
AP0515 -    070301 1505..... 112  69     86 *   36.6c            98
AP0516 -    070222 1145..... 115  73     58     36.3c   147      98
AP0517 -    070222 1045..... 100  60     56     36.6c   147      98
AP0518 -    070222 0930..... 117  63     68     36.2c   147      97
AP0519 -    070215 1200..... 106  66     61     37.0c   147      97
AP0520 -    070215 1055.....  96  61     64     37.0c   147      94
AP0521 -    070215 0930..... 100  64     66     36.7c   147      98
AP0522 -    070208 0920..... 143  70     59     36.5c   147      98
AP0523 -    070201 1330..... 136  74     66             148      94
AP0524 -    070201 1220..... 110  65     62     36.3c   148      96
AP0525 -    070201 1000..... 132  80     65     36.9c   148      99
AP0526 -    061201 1534..... 123  76     76     97.5    150
AP0527 -    061110 1534..... 136  83     73     97.0    150      98
AP0528 -    061020 1534..... 140  79     67     99.8    151      97
AP0529 -    060929 1452..... 141  78     66     98.3    149
AP0530 -    060908 1335..... 139  79     73     98.1    149
AP0531 -    060814 1610..... 139  80     59     98.2    151
AP0532 -    060722 1440..... 142  74     67     98.1    149
AP0533 -    060711.......... 172  87     54     97.5    147
AP0534 -    060623.......... 141  87     71     98.0    147
AP0535 -    060428.......... 129  73     80     99.4    149
AP0536 -    060217.......... 153  81     61     98.6    150
AP0537 -    050916.......... 120  80     80     98.5
AP0538 -
AP0539 -  *  Need vitals taken twice to verify atypical diagnostics.
AP0540 -
AP0541 -
AP0542 -
AP0543 -
AP06 -

SUBJECTS
Energy Normal Stable Alert Drive Home After Treatment IBC 3rd Relaps

AS03 -
AS04 - 1310
AS0501 -  ..
AS0502 - Energy Normal Stable After Treatment Cetuximab Support Drugs
AS0503 -
AS0504 - Follow up ref SDS E8 F54N, ref SDS E5 F54N.
AS0506 -  ..
AS0507 - On 060724 diary side effects for cetuximab chemotherapy treatment on
AS0508 - clinical study drug trial. ref SDS 93 YP4I
AS0510 -  ..
AS0511 - Millie reported side effects today normal energy. ref SDS 0 FG3N
AS0513 -  ..
AS0514 - Millie was alert after treatment again today, and not wobbly nor
AS0515 - disoriented.  She was able to drive home without side effects of
AS0516 - treatment.
AS0517 -
AS0518 -
AS0519 -
AS0520 -
AS0521 -
AS0522 -
AS0523 -
AS0524 -
AS0525 -
AS06 -