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 22, 2007 08:30 AM Thursday; Rod Welch

Millie at UCSF 2nd cycle 4th 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...Emotional Roller Coaster Endemic Cancer Treatment and Coordination
5...Cetuximab Prognosis IBC May Subside for 10 Months Before Progressing
6...Prognosis Disease May Subside 10 Months or More Before Progression
7...Progresssion of Disease May be Delayed for 10 Months or More
8...Measureable Disease Photographs IBC Rash Improving
9...IBC Rash Improved Measurable Disease Photographs Tape Measure
10...Side Effects Medicated After Weekly Examinations
11...Blood Tests 1 Per Month on Cetuximab Performed at UCSF Saves Time Cost
12...Infusion Clinic for Cetuximab Treatent
..........Taxotere Capecitabine
..........Cetuxiab Clinical Study
13...Nurses Notes...
14...Side Effects Consultation Pharmacist Heavy Chest Difficult Breathing
15...Schedule Weekly Treatments Continue on Thursdays
16...Blood Counts Normal Full Dose Cetuximab Ordered
17...Blood Test Not Scheduled Infusion Clinic Took Approprite Action
18...Coagulation Control INR High 2.5 PT 28 High
19...ANC 1510 Below 1800 Criteria for Blood Counts to Approve Treatment
20...CA 15-3 36 Tests 2 From Kaiser 1 from UCSF Pending Submission
21...Preparation for Treatment Required One (1. Attempt to Connect Port
22...Blood Draws 7 Vials for Clinical Study Research
23...Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
24...Cetuximab Full Dose Blood Counts on Targets Treatment 1 Hour
25...Vitals Show Patient Stable
26...Energy Normal Stable After Treatment Cetuximab Support Drugs

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

1...Why is the visit number constant in Nurse's Notes, and yet seems to

CONTACTS 

SUBJECTS
Treatment Cetuximab 4th Treatment 2nd Cycle Chemotherapy 10th Cycle

0603 -
0603 -    ..
0604 - Summary/Objective
0605 -
060501 - Follow up ref SDS 28 0000. ref SDS 26 0000.
060502 -
060503 - Millie received the 4th treatment today to complete the 2nd cycle with
060504 - cetuximab on a drug trial in a clinical study at UCSF under the
060505 - supervision of Doctor Rugo. ref SDS 0 7T3H  Catherine was back at
060506 - work, and did an excellent job following the protocol, reviewing side
060507 - effects, ref SDS 0 QU8K, and providing professional care. ref SDS 0
060508 - 417F  Millie reported expanding side effects problems of drying skin.
060509 - Catherine consulted the pharmacy.  A new medication was prescirbed.
060510 - ref SDS 0 JS6M  "Restless legs" was also presented today, caused by
060511 - Benadryl, and this was addressed by slowing the rate of drip treatment
060512 - infusion. ref SDS 0 F77K  Millie reported that the "restless legs"
060513 - problem was reduced.  The chemotherapy order calls for pre-treatment
060514 - 30 - 60 minutes prior to cetuximab infusion.  This may provide
060515 - additional time to further moderate this problem, if needed.
060516 - ref SDS 0 DC7J
060517 -
060518 -
060519 -
060521 -  ..
0606 -
0607 -
0608 - Progress
0609 -
060901 - Clinic Examination Orientation Starting Treatment Cetuximab
060902 -
060903 - Follow up ref SDS 28 407N, ref SDS 26 407N.
060905 -  ..
060906 - Agenda...
060907 -
060908 -    1.  Infusion Clinic........................... ref SDS 0 1M6H
060909 -    2.  Side effects.............................. ref SDS 0 QU8K
060910 -    3.  Vitals.................................... ref SDS 0 AW4L
060911 -
060912 -
060913 -
0610 -

SUBJECTS
Breast Examination Shows Improvement IBC Rash Intensity Subsides No

1103 -
110401 -  ..
110402 - Breast Examination Likely IBC 2 Scenarios Spreading Intensity Declines
110403 -
110404 - Follow up ref SDS 28 FO6H, ref SDS 26 FO6H.
110405 -
110406 -
110407 -
110408 -
110409 -
1105 -

SUBJECTS
Emotional Stress Roller Coaster Endemic Cancer Treatment Erratic Cha

1603 -
160401 -  ..
160402 - Emotional Roller Coaster Endemic Cancer Treatment and Coordination
160403 -
160404 - Follow up ref SDS 28 6A7J, ref SDS 22 Y642.
160405 -
160406 -
160407 -
160408 -
160409 -
1605 -

SUBJECTS
Cetuximab Prognosis IBC May Subside for 10 Months Before Progressing

1903 -
190401 -  ..
190402 - Cetuximab Prognosis IBC May Subside for 10 Months Before Progressing
190403 - Prognosis Disease May Subside 10 Months or More Before Progression
190404 - Progresssion of Disease May be Delayed for 10 Months or More
190405 -
190406 - Follow up ref SDS 28 6A9H.
190407 -
190408 - No meeting with medical management team today.
190409 -
190410 -
190411 -
1905 -

SUBJECTS
Measureable Disease IBC Rash Tape Measure Evaluate Progression of Di

2203 -
220401 -  ..
220402 - Measureable Disease Photographs IBC Rash Improving
220403 - IBC Rash Improved Measurable Disease Photographs Tape Measure
220404 -
220405 - Follow up ref SDS 28 6T6M, ref SDS 26 6T6M.
220406 -
220407 - No meeting with medical management team today.
220408 -
220409 -
220410 -
220411 -
220412 -
2205 -

SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A

2703 -
270401 -  ..
270402 - Side Effects Medicated After Weekly Examinations
270403 -
270404 - Follow up ref SDS 28 FO66, ref SDS 26 FO66.
270405 -
270406 - No meeting with medical management team today.
270407 -
270408 -
270409 -
2705 -

SUBJECTS
Blood Tests Cetuximab Monthly Clinical Study Drug Trial Performed at

3003 -
300401 -  ..
300402 - Blood Tests 1 Per Month on Cetuximab Performed at UCSF Saves Time Cost
300403 -
300404 - Follow up ref SDS 28 XR40, ref SDS 26 XR40.
300405 -
300406 - The next blood test is scheduled for 070329.
300407 -
300408 -
300409 -
300410 -
3005 -

SUBJECTS
Cetuximab 2nd Cycle 4th Treatment 8th Total Treatment Chemotherapy 9

3303 -
3304 - 0845
330501 -  ..
330502 - Infusion Clinic for Cetuximab Treatent
330503 -
330504 - Follow up ref SDS 28 1M6H, ref SDS 26 1M6H.
330505 -
330506 - Millie was scheduled last week for treatments through May. ref SDS 28
330507 - E29H  Nola said she could enter the clinic immediately for treatment.
330509 -  ..
330510 - Catherine was back at work today, and was very effective implementing
330511 - the drug trial protocol for cetuximab, including review of side
330512 - effects, taking vitals, and providing a high level of professional
330513 - care.
330515 -  ..
330516 - Catherine discussed advantages of continuity of nurse staffing to
330517 - treat complex cases, shown by problems on 070301, ref SDS 23 GZ5I, the
330518 - following week on 070308, ref SDS 26 FF41, and again last week on
330519 - 070315. ref SDS 28 1M6H  Using the same nurse as much as possible
330520 - reduces problems of overlooking side effects, recognizing new issues,
330521 - and understanding the protocol.
330522 -
330523 -     [On 070809 Catherine not available; substitute had difficulty
330524 -     understanding protocol; blood test performed out of sequence
330525 -     because having others pay for an unnecessary test is faster and
330526 -     easier for the staff than checking the record to verify accuracy
330527 -     of treatment. ref SDS 34 7U7J
330528 -
330529 -
330530 -
330531 -
330533 -  ..
3306 -
3307 -
3308 - 1033
3309 -
330901 - Millie received 8th overall and 4th treatment of 2nd cycle with
330902 - Cetuximab, starting from 070201, ref SDS 14 G68I, and the 15th
330903 - treatment for 3rd relapse of IBC, beginning on 060721. ref SDS 4 407N
330905 -           ..
330906 -          Taxotere Capecitabine
330907 -
330908 -          Follow up ref SDS 28 PR8Q, ref SDS 26 PR8Q.
330909 -
330910 -                   Relapse Treatments
330911 -
330912 -      1.  Cycle 09 and 01 ................... 060721, ref SDS 4 407N
330913 -      2.  Cycle 10 and 02 ................... 060814, ref SDS 7 LY6O
330914 -      3.  Cycle 11 and 03 ................... 060908, ref SDS 8 407N
330915 -      4.  Cycle 12 and 04 ................... 060929, ref SDS 9 407N
330916 -      5.  Cycle 13 and 05 ................... 061020, ref SDS 10 407N
330917 -      6.  Cycle 14 and 06 ................... 061110, ref SDS 11 407N
330918 -      7.  Cycle 15 and 07 ................... 061201, ref SDS 12 407N
330920 -           ..
330921 -          Cetuxiab Clinical Study
330922 -
330923 -          Follow up ref SDS 28 7T3H, ref SDS 26 7T3H.
330924 -
330925 -                   Total    Cetuximab
330926 -      8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 14 SG8I
330927 -      9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 16 7T3H
330928 -     10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 17 7T3H
330929 -     11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 20 7T3H
330930 -     12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 23 7T3H
330931 -     13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 26 7T3H
330932 -     14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 28 7T3H
330933 -     15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 0 7T3H
330935 -  ..
330936 - Nurses Notes...
330947 -  ..
330948 - Why is the visit number constant in Nurse's Notes, and yet seems to
330949 - vary in the schedule received from Nola last week? ref SDS 28 159O
330950 -
330952 -     ..
330953 -    UCSF Log Time...
330954 -
330955 -                   Blood
330956 -                    Test   Infusion
330957 -
330958 -          In.......          0830
330959 -          Out......          1100
330960 -          Visit....      Min  2.5  Hours
330962 -      ..
330963 -     Pain Assessment...
330964 -
330965 -          x
330966 -          0123456789 10
330967 -
330968 -     <923k
330969 -     Administration Site:  Right Port Catheter
330970 -     Needle Size:          20 G 1"
330971 -     Blood Return Good:    Yes
330973 -      ..
330974 -     Remind patient to call MD if temp > 101 F, Shaking Chills
330975 -
330976 -            This protocol differs from Kaiser requirements, reported on
330977 -            041202. ref SDS 2 IX9N
330978 -
330979 -
330980 -
330981 -
3310 -

SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A

4103 -
4104 - 0910
410501 -  ..
410502 - Side Effects Consultation Pharmacist Heavy Chest Difficult Breathing
410503 -
410504 - Follow up ref SDS 28 QU8K, ref SDS 26 QU8K.
410506 -  ..
410507 - Millie was asked about side effects today, which corrected the problem
410508 - on 070308. ref SDS 26 QG7K
410509 -
410510 -        1.  Rash like acne
410511 -
410512 -               Mild condition continues from 070208 around the nose,
410513 -               ref SDS 16 QU8K; treatment effective with medication
410514 -               prescribed on 070222. ref SDS 20 FO66
410516 -             ..
410517 -        2.  Dry skin face, chest arm...
410518 -
410519 -               Millie notified UCSF in a letter on 070228 of sudden
410520 -               extremely dry face. ref SDS 21 LR4S  The next day, on
410521 -               070301, Brigid prescribed Curel lotion. ref SDS 22 5V73
410522 -               Since that time, treatment with Curel has brought some
410523 -               relief, per examination by Brigid prior to treatment
410524 -               last week on 070315. ref SDS 28 6B8H  Today, dryness has
410525 -               spread to chest, and arms.  Catherine called the
410526 -               pharmacy.  Recommended trying Aquaphor to relieve
410527 -               chronic skin dryness.  On the way home, Millie stopped
410528 -               at Long's Drugs and purchased this treatment, described
410529 -               on the bottle as "Advanced Therapy."
410530 -
410531 -                  [On 070329 Millie looks great, and feels fortunate to
410532 -                  have avoided severe skin rash side effects of
410533 -                  cetuximab by applying treatment prescribed by Brigid.
410534 -                  ref SDS 31 N49K
410536 -             ..
410537 -        3.  Rash on right chest
410538 -
410539 -               Examination of upper right chest observes various
410540 -               blemishes in the proximate area of the port catheter.
410541 -               These are not identified in Nurses's Notes today as a
410542 -               "rash," which clarifies reports of observations during
410543 -               examination and treatment last week on 070315.
410544 -               ref SDS 28 KU3L  This issue is distinct from IBC rash
410545 -               slighlty on the right breast, which is being tracked as
410546 -               measurable disease by the examination team, reported on
410547 -               070315. ref SDS 28 FO6H
410549 -                   ..
410550 -                  [On 070330 examination at Kaiser by primary care
410551 -                  physician finds significantly increased intensity of
410552 -                  rash on upper left arm, ref SDS 33 N19J, and a
410553 -                  similar new rash above the right breast and below the
410554 -                  colar bone, ref SDS 33 583G; these dramatic changes
410555 -                  in condition were diagnosed without biopsy as
410556 -                  complications of lymphedema causing Cellulitis with
410557 -                  elevated temperature, and possibly triggered by
410558 -                  patient's increased exercise that overtaxed the
410559 -                  system. ref SDS 33 7C7F  Keflex antibiotics was
410560 -                  prescribed, ref SDS 33 474O; about 3 hours later
410561 -                  self-examination showed these erruptive rash
410562 -                  conditions had subsided, and so Keflex treatment was
410563 -                  not performed. ref SDS 33 KZ6L
410565 -             ..
410566 -        4.  Rash right arm
410567 -
410568 -               Millie discussed occassional red dots and blemishes that
410569 -               occur on the right arm, examined by Brigid during last
410570 -               week on 070315. ref SDS 28 FO6H  There is a concern
410571 -               about IBC spreading, or side effects of cetuximab
410572 -               treatment.  Today, Catherine seemed to indicate there is
410573 -               no evidence of any distinct rash on the right arm.
410574 -
410576 -             ..
410577 -        5.  Restless legs
410578 -
410579 -               Millie described "restless legs," reported in the record
410580 -               following treatment last week on 070315. ref SDS 28 F77K
410581 -               Catherine slowed the rate of Benadryl pre-treatment
410582 -               medication, from 10 to 20 minutes. ref SDS 0 DC7J  After
410583 -               treatment today, Millie feels this change brought some
410584 -               relief today.  Maybe next week, Benadryl pre-treatment
410585 -               can be given over 30 minutes, which seems to be
410586 -               supported by the chemotherapy order. ref SDS 0 WR4H
410587 -
410588 -                   [On 070329 prescription for Benadryl changed from 50
410589 -                   mg to 25 mg. ref SDS 31 MF6N
410591 -                    ..
410592 -                   [On 070329 "restless legs" problem with Benadryl
410593 -                   resolved with Brigid's change in treatment dose.
410594 -                   ref SDS 32 F77K
410596 -             ..
410597 -        6.  Sleeping difficulty
410598 -
410599 -               Over the past 2 -4 weeks, there has been gradually
410600 -               increased difficulty sleeping.  This occurs by staying
410601 -               up later than 2000, until 2200 or in some cases later;
410602 -               Millie has been rising earlier at 0430 or even 0300.
410603 -               Sometimes after getting up to go to the bathroom, Millie
410604 -               has difficulty falling to sleep.  Normally, Millie gets
410605 -               at least 8 hours sleep, and sleeps soundly.  This makes
410606 -               the change in sleep evident.  The only previous report
410607 -               of sleep issues was on 020726, which seemed related to
410608 -               radiation treatments, but was not serious and did not
410609 -               last. ref SDS 1 YX7O
410611 -                ..
410612 -               Last year on 060721, Ativan was prescribed by Kaiser to
410613 -               aid sleep and relieve anxiety from the 3rd relapse of
410614 -               IBC. ref SDS 4 FZ5N  The current cause of difficulty
410615 -               sleeping may be accumulating side effects to cetuximab,
410616 -               and/or emotional trauma and anxiety, doubt, and worry
410617 -               about effectiveness of treatment reported on 070301, and
410618 -               shown by elevated vitals at that time. ref SDS 22 Y642
410619 -               Last week on 070315, Brigid asked Millie about coping
410620 -               with emotional swings from recent changes in prognosis
410621 -               and treatments, consideration of changing treatment.
410622 -               ref SDS 28 6A7J  Another cause of anxiety that makes
410623 -               sleep difficult is difficulty coordinating the work,
410624 -               also, reviewed on 070315. ref SDS 28 OR5K  Difficulty
410625 -               sleeping may manifest anxiety, doubt, and worry that is
410626 -               not evident from Millie's calm, measured demeanor
410627 -               working with complex communications that delay and
410628 -               frustrate getting things done. ref SDS 28 ES3K
410629 -
410630 -                  [On 070329 stress, anxiety, doubt, worry relieved by
410631 -                  good medical news, and increases by difficulty
410632 -                  managing communications. ref SDS 31 II7H
410634 -             ..
410635 -        7.  Lymphedema Cellulitis Complications
410636 -
410637 -               Lymphedema continues relatively controlled.  There is no
410638 -               association with cetuximab treatments, since the
410639 -               proximate cause was left breast mastectomy with removal
410640 -               of lymph nodes in the left axillar, and is complicated
410641 -               by exercise to strengthen the immune system for
410642 -               resisting cancer, and by cat bites that flow from
410643 -               engaging pets for qualify of life, reported in the case
410644 -               study on 070130. ref SDS 13 VX6F
410645 -
410646 -                  [On 070330 examination at Kaiser by primary care
410647 -                  physician finds significantly increased intensity of
410648 -                  rash on upper left arm, ref SDS 33 N19J, and a
410649 -                  similar new rash above the right breast and below the
410650 -                  colar bone; these dramatic changes in condition were
410651 -                  diagnosed without biopsy as complications of
410652 -                  lymphedema causing Cellulitis with elevated
410653 -                  temperature, and possibly triggered by patient's
410654 -                  increased exercise that overtaxed the system.
410655 -                  ref SDS 33 583G  Keflex antibiotics was prescribed,
410656 -                  ref SDS 33 474O; about 3 hours later self-examination
410657 -                  showed these erruptive rash conditions had subsided,
410658 -                  and so Keflex treatment was not performed.
410659 -                  ref SDS 33 KZ6L
410661 -             ..
410662 -        8.  Tired, fatigued - pulmonary emoblism...
410663 -
410664 -               Fatigue, shortness of breath and other symptoms of
410665 -               pulmonary embolism were presented during meeting on
410666 -               070130, ref SDS 13 CV5L, citing case study listed on
410667 -               060722. ref SDS 5 ZV41
410669 -                ..
410670 -               On 070218 Millie notified the primary care physician and
410671 -               UCSF that energy continues to recover; she played tennis
410672 -               and pulse reached 144. ref SDS 18 N05H
410674 -                ..
410675 -               Energy that seemed to be declining leading up to
410676 -               treatment on 070301, ref SDS 23 CA4K, seems to be rising
410677 -               back to normal the past few weeks, continuing trends
410678 -               reported last week on 070315. ref SDS 28 CA4K  Catherine
410679 -               asked if Millie has played any more tennis?  Millie has
410680 -               not played tennis, but has worked out more in the gym,
410681 -               including the stationary bike for several hours at a
410682 -               time.
410683 -
410685 -             ..
410686 -        9.  Heavy chest - shortness of breathing
410687 -
410688 -               Patient history was reported to UCSF on 070130.
410689 -               ref SDS 13 RT6I
410690 -
410691 -               Condition seems improved, as reported on 070204.
410692 -               ref SDS 15 JJ7O  No noticable increase, aligns with
410693 -               continuing higher energy. ref SDS 0 CA4K
410694 -
410696 -             ..
410697 -       10.  Cough - clearing throat
410698 -
410699 -               This condition seems improved, as reported to the doctor
410700 -               on 070130. ref SDS 13 RT6I
410701 -
410703 -             ..
410704 -       11.  Dry hands and feet...
410705 -
410706 -               Dry hands and feet seem much improved since ending
410707 -               treatment with Taxotere and capecitiabine on 061201.
410708 -
410710 -             ..
410711 -       12.  Eyes tearing
410712 -
410713 -               This seems improved since ending treatment with Taxoter
410714 -               and capecitabine on 061201.
410715 -
410717 -             ..
410718 -       13.  Nausea and vomitting
410719 -
410720 -               Problems with Taxotere and capecitabine reported on
410721 -               061110, ref SDS 11 D19M, did not occur this past week
410722 -               after treatment with cetuximab.  As a result, there was
410723 -               no pre-treatment with Decadron today, per below.
410724 -               ref SDS 0 G57I
410726 -             ..
410727 -       14.  Sores in mouth
410728 -
410729 -               None yet, cleaning mouth carefully to avoid problem.
410730 -
410731 -
410732 -
410733 -
4108 -

SUBJECTS
Schedule Treatment Weekly Thursday 0800 4 Week Cycles Clinical Study

4403 -
440401 -  ..
440402 - Schedule Weekly Treatments Continue on Thursdays
440403 -
440404 - Follow up ref SDS 28 QK6L, ref SDS 26 QK6L.
440406 -  ..
440407 - Millie's next treatment is scheduled for 070329 0845, reported by Nola
440408 - on 070315. ref SDS 28 159O
440410 -  ..
440411 - There are issues to work out in order to have the blood test done in
440412 - time for meeting with Doctor Rugo at 0800, since the Infusion Clinic
440413 - does not start work until 0830.  On 070315, considered somone might
440414 - normally come in early in the Infusion Clinic, and could draw blood
440415 - and configure Millie with a port connection for treatment after
440416 - meeting with the doctor. ref SDS 28 WU6F
440417 -
440418 -     [On 070326 presented scheduling plans to UCSF for getting blood
440419 -     tests, examination, and treatment at the same time. ref SDS 29
440420 -     624X
440422 -      ..
440423 -     [On 070326 coordinated to schedule blood tests in advance of
440424 -     normal hours. ref SDS 29 PP5Y
440426 -      ..
440427 -     [On 070327 Jackie submitting "lab slips" ordering blood tests for
440428 -     Infusion Clinic to draw blood at 0800 on 070329. ref SDS 30 MT6Q
440430 -      ..
440431 -     [On 070329 blood tests, examination and treatment scheduling
440432 -     issues were resolved. ref SDS 32 UZ4J
440433 -
440434 -
440435 -
440436 -
440437 -
440438 -
4405 -

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

4703 -
4704 - 0840
470501 -  ..
470502 - Blood Counts Normal Full Dose Cetuximab Ordered
470503 - Blood Test Not Scheduled Infusion Clinic Took Approprite Action
470504 -
470505 - Follow up ref SDS 28 Q659, ref SDS 26 Q659.
470506 -
470507 - The next blood test is scheduled for 070329.
470508 -
470509 -
470510 -
470511 -
4706 -

SUBJECTS
Coagulation Control Coumadin Treatment Pulmonary Embolism INR 2.5 PT

5403 -
540401 -  ..
540402 - Coagulation Control INR High 2.5 PT 28 High
540403 -
540404 - Follow up ref SDS 28 SE6N, ref SDS 26 SE6N.
540405 -
540406 - Next blood test for INR is on 070426, per planning on 070308.
540407 - ref SDS 26 CS6J
540408 -
540409 -
540410 -
540411 -
5405 -

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

5703 -
570401 -  ..
570402 - ANC 1510 Below 1800 Criteria for Blood Counts to Approve Treatment
570403 -
570404 - Follow up ref SDS 28 P560, ref SDS 26 P560.
570405 -
570406 - The next blood test is scheduled for 070329.
570407 -
570408 -
570409 -
570410 -
5705 -

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

6203 -
620401 -  ..
620402 - CA 15-3 36 Tests 2 From Kaiser 1 from UCSF Pending Submission
620403 -
620404 - Follow up ref SDS 28 2N5J, ref SDS 26 2N5J.
620405 -
620406 - The next blood test is scheduled for 070329.
620407 -
620408 -
620409 -
6205 -

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

6503 -
6504 - 0835
650501 -  ..
650502 - Preparation for Treatment Required One (1. Attempt to Connect Port
650503 -
650504 - Follow up ref SDS 28 EB7J, ref SDS 26 EB7J.
650506 -  ..
650507 - The nurse connected the IV tubes to the port....
650509 -       ..
650510 -      Interlink System Vented Paclitaxel set
650512 -  ..
650513 - Like last week and earlier on 070301, there were no problems getting
650514 - blood to flow from the port, ref SDS 23 EB7J, as occurred on 070222,
650515 - ref SDS 19 DC5W, and earlier on 070201. ref SDS 14 DC5W
650517 -  ..
650518 - The nurse flushed the port with saline.
650519 -
650520 -
650521 -
650522 -
6506 -

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

6903 -
690401 -  ..
690402 - Blood Draws 7 Vials for Clinical Study Research
690403 -
690404 - Follow up ref SDS 28 O56V, ref SDS 26 O56V.
690405 -
690406 - There were no blood draws today, because the study requires blood for
690407 - research only at the beginning of each cycle, and this is the 2nd
690408 - treatment in the 2nd cycle.
690409 -
690410 -
690411 -
690412 -
690413 -
6905 -

SUBJECTS
Benadryl Pre-treatment Prepares Patient for Cetuximab Chemotherapy A

7303 -
7304 - 0840
730501 -  ..
730502 - Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
730503 -
730504 - Follow up ref SDS 28 DC7J, ref SDS 26 DC7J.
730505 -
730506 - Benadryl (diphenhydramine) started.   50 MG....... ref SDS 0 IJ41
730507 -
730508 -        Purpose reported on 060721. ref SDS 4 DC7J
730510 -  ..
730511 - Chemotherpay order calls for Benadryl (diphenhydramine) pre-treatment
730512 - 30 - 60 minutes prior to cetuximab infusion, shown below. ref SDS 0
730513 - IJ41
730515 -  ..
730516 - For some reason this requirement for Benadryl treatment has never been
730517 - implemented.  The practice at Kaiser over the past 5 years, and this
730518 - year at UCSF, beginning on 070201, ref SDS 14 DC7J, has been to start
730519 - primary treatment immediately after 10 minutes of Benadryl infusion.
730520 - ref SDS 0 4N5M
730521 -
730522 -            [On 070329 Chemotherapy Order reviewed during examination
730523 -            and was not changed for pre-treatment 30 - 60 minutes prior
730524 -            to cetuximab treatment. ref SDS 31 MF4N
730526 -             ..
730527 -            [On 070329 prescription for Benadryl changed from 50 mg to
730528 -            25 mg. ref SDS 31 MF6N
730530 -  ..
730531 - Perhaps the Infusion Clinic has a standing order (i.e., policy) that
730532 - supports deviation from the chemotherapy order, or the order was
730533 - modified after 070201, and not submitted to the patient.  Perhaps,
730534 - like Decadron, pre-treatment timing is adjusted according to patient
730535 - history, and up until recenlty, there has not been an issue.
730537 -  ..
730538 - There may be some correlation between planning Benadryl treatment 30 -
730539 - 60 minutes prior to cetuximab, and the new problem of restless legs.
730540 - ref SDS 0 CC4I
730541 -
730542 -            [On 070329 prescription for Benadryl changed from 50 mg to
730543 -            25 mg. ref SDS 31 MF6N
730544 -
730545 -
730547 -  ..
7306 -
7307 -
7308 - 0900
7309 -
730901 - Benedryl completed equipment beeps.
730902 -
730903 - This took 20 minutes, rather than 10 minutes for previous treatments,
730904 - in order to reduce the effect of "restless legs," reported last week,
730905 - ref SDS 28 DC7J, and again today, per above. ref SDS 0 F77K
730907 -  ..
730908 - After treatment, Millie reported that increasing the time for Benadryl
730909 - infusion today from 10 to 20 minutes seemed to reduce side effects of
730910 - "restless legs."  Possibly this can be further improved within the
730911 - chemotherapy order for pre-treatments 30 - 60 minutes prior to
730912 - cetuximab. ref SDS 0 IJ41
730913 -
730914 -            [On 070329 prescription for Benadryl changed from 50 mg to
730915 -            25 mg. ref SDS 31 MF6N
730916 -
730917 -
730919 -  ..
7310 -
7311 -
7312 -
7313 -
731301 - Decadron (dexamethasone) IV pre-treatment........ ref SDS 0 FM4M
731302 -
731303 - On 070208 Decadron was not given because Millie did not experience
731304 - side effects of nausea and vomitting after treatment with cetuximab on
731305 - 070201. ref SDS 16 G57I  Since this favorable condition continues, per
731306 - above, ref SDS 0 D19M, Decadron was not given again today.
731307 -
731308 -            [On 070329 Chemotherapy Order reviewed during examination
731309 -            and was not changed for pre-treatment 30 - 60 minutes prior
731310 -            to cetuximab treatment. ref SDS 31 MF4N
731311 -
731313 -  ..
7314 -
7315 -
7316 -
731601 - Decadron completed -- not reported.
731602 -
731603 -
731604 -
731605 -
7317 -

SUBJECTS
Cetuximab 2nd Cycle 4th Treatment Clinical Study Drug Trial Treatmen

7503 -
7504 - 0910
750501 -  ..
750502 - Cetuximab Full Dose Blood Counts on Targets Treatment 1 Hour
750503 -
750504 - Follow up ref SDS 28 4N5M, ref SDS 26 4N5M.
750506 -  ..
750507 - Cetuximab started.
750508 -
750509 -           Verify chemotherapy order for 070208.
750511 -  ..
750512 - Chemotherapy order calls for cetuximab to start 30 - 60 minutes after
750513 - Beyadryl pre-tretment. ref SDS 0 IJ41
750515 -  ..
750516 - Chemotherapy Orders...
750517 -
750523 -    Auth#                                     Stor BCC LOC
750524 -    Visit:  12575738             DOS 20070201
750526 -     ..
750527 -    Date:  20070201
750529 -     ..
750530 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
750531 -    in combination with Carboplatin in ER-negative, PR-negative,
750532 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers
750534 -     ..
750535 -    Dates to be given:  070201
750536 -    Arm 1:Cetuximab alone
750538 -     ..
750539 -    Diagnosis:  breast cancer
750541 -     ..
750542 -    ICD-9 codes: 174.9
750543 -    Allergies  NKDA
750545 -     ..
750546 -    Pre-medications 30 - 60 minutes prior to cetuximab infusion
750548 -     ..
750549 -    4. Diphenhydramine 50 mg IV or  [illegible writing]
750550 -
750551 -       Benadryl........... ref SDS 0 DC7J
750552 -
750553 -            [On 070329 Chemotherapy Order reviewed during examination
750554 -            and was not changed for pre-treatment 30 - 60 minutes prior
750555 -            to cetuximab treatment. ref SDS 31 MF4N
750557 -             ..
750558 -            [On 070329 prescription for Benadryl changed from 50 mg to
750559 -            25 mg. ref SDS 31 MF6N
750561 -     ..
750562 -    5. Dexamethasone (??) 10 mg IB or 20 mg IV [handwritten ???]
750563 -
750564 -       Further premed TBD [barely legible handwriting??]
750565 -
750566 -            [On 070329 Chemotherapy Order reviewed during examination
750567 -            and was not changed for pre-treatment 30 - 60 minutes prior
750568 -            to cetuximab treatment. ref SDS 31 MF4N
750570 -     ..
750571 -    Medication:  (plan to give weekly ********STUDY SUPPLY**********
750573 -     ..
750574 -    6. Cetuximab (Erbitux) (loading dose)
750575 -
750576 -              400 mg/m [squared] = 684 mg IV over 120 minutes for
750577 -              first dose x 1
750578 -
750579 -       dose on dcte 20070201   Maximum infusion rate is 5 ml/minute
750580 -       (concentration 2 mg/ml)
750582 -     ..
750583 -    7. Cetuximab (Erbitux) (maintenance dose)
750584 -
750585 -              250 mg/m [squared] = 428 mg IV (or ____ mg/m[squared] =
750586 -              ____mg) IV over 60 or ____ minutes.
750587 -
750588 -       Maximum infusion rate is 5 ml/minute (concentration 2 mg/ml)
750589 -       Infuse once weekly for 8 weeks.  First dose to be given on date
750590 -       20070201.
750592 -        ..
750593 -       Cetuximab is administered undiluted through a low protien
750594 -       binding 0.22 micro in-line filter.  Use NS solution to flush the
750595 -       line at the end of the infusion.
750597 -        ..
750598 -       ARM 2:  Administer carboplatin of vital signs are unremarkable
750599 -       one hour after cetuximab infusion.
750601 -        ..
750602 -       Vital signs at baseline, upon cetuximab completion and one hour
750603 -       after cetuximab.
750604 -
750605 -       ****please note start and stop times****
750607 -        ..
750608 -       Laboratory work:
750609 -
750610 -          See carboplatin orders
750612 -        ..
750613 -       x  Notify MD for dose modifications if patient has severe
750614 -          acne in form rash
750615 -
750616 -          CBC with differential and platletes every 4 weeks
750617 -          Creatinine and magnesium every 4 weeks
750618 -          BUN AST Alk phos Alt Total bilrubin, electrolyes every 8
750619 -          weeks.  If levels are outside of normal laboratory values
750620 -          notify Brigid NP  (MD/RN) at 415 443 4730
750622 -        ..
750623 -       x  Physician has discussed risks/benefits of therapy with the
750624 -          patient.  Signed consent obtained.
750625 -
750626 -
750627 -          Yes  No   O2 by nasal cannula at 2 liters/min prn for chest
750628 -          pain or SOB
750630 -           ..
750631 -          Yes  No   Diphenhydramine 50 mg IV prn x1 for urticaria
750632 -          [barely legible], pruritis SOB
750634 -           ..
750635 -          Yes  No   Hydrocortizone 100 mg IV prn x1 for urticaria
750636 -          [barely legible], pruritis SOB
750638 -           ..
750639 -          Yes  No   Albuterol inhaler 2-4 puffs prn SOB or chest
750640 -          tightness
750642 -           ..
750643 -          Yes  No   Epinephrine 1x1000 (1 mg/ml) 0.3 mg IV prn
750644 -          anaphylaxis
750646 -           ..
750647 -          Breast CC05752 Cetuximab doc 20061024
750648 -          Approved 20060615
750650 -           ..
750651 -          Physician signature [Hope Rugo]
750653 -           ..
750654 -          Provider#  35313
750656 -           ..
750657 -          Date:  20010131
750658 -
750660 -  ..
7507 -
7508 -
7509 - 1010
7510 -
751001 - Cetuximab treatment completed.
751002 -
751003 - Millie had a 1 hour rest and observation period, required by the
751004 - protocol. ref SDS 0 G679
751005 -
751006 -
751007 -
751009 -  ..
7511 -
7512 -
7513 - 1100
7514 -
751401 - Catherine disconnected the IV tubes.
751403 -  ..
751404 - She inserted Herceptin to flush the port.
751406 -  ..
751407 - She then removed the needle from the port, and swabbed the needle
751408 - wound, and placed a temporary bandage.
751409 -
751410 -
751411 -
751412 -
751413 -
7515 -

SUBJECTS
Vitals Blood Pressure Pulse Temperature Sa02 Weight Infusion Treatme

7803 -
7804 - 0900
780501 -  ..
780502 - Vitals Show Patient Stable
780503 -
780504 - Follow up ref SDS 28 AW4L, ref SDS 26 AW4L.
780505 -
780506 -                     Blood
780507 -    Date   Time    Pressure  Pulse  Temprtr Weight  SaO2
780509 -     ..
780510 -    070322 1055..... 118  71     55     37.0c             97
780511 -    070322 1015..... 120  69     57     37.1c             98
780512 -    070322 0900..... 130  70     56     36.0c             98
780513 -    070315 1300..... 119  75     58     36.2c             98
780514 -    070315 1150..... 137  73     52     36.5c             99
780515 -    070315 0945..... 143  85     60     36.4c             97
780516 -    070308 1100..... 144  87     70     36.0c             98
780517 -    070301 1645..... 125  62     90 *   36.4c
780518 -    070301 1505..... 112  69     86 *   36.6c             98
780519 -    070222 1145..... 115  73     58     36.3c    147      98
780520 -    070222 1045..... 100  60     56     36.6c    147      98
780521 -    070222 0930..... 117  63     68     36.2c    147      97
780522 -    070215 1200..... 106  66     61     37.0c    147      97
780523 -    070215 1055.....  96  61     64     37.0c    147      94
780524 -    070215 0930..... 100  64     66     36.7c    147      98
780525 -    070208 0920..... 143  70     59     36.5c    147      98
780526 -    070201 1330..... 136  74     66              148      94
780527 -    070201 1220..... 110  65     62     36.3c    148      96
780528 -    070201 1000..... 132  80     65     36.9c    148      99
780529 -    061201 1534..... 123  76     76     97.5     150
780530 -    061110 1534..... 136  83     73     97.0     150      98
780531 -    061020 1534..... 140  79     67     99.8     151      97
780532 -    060929 1452..... 141  78     66     98.3     149
780533 -    060908 1335..... 139  79     73     98.1     149
780534 -    060814 1610..... 139  80     59     98.2     151
780535 -    060722 1440..... 142  74     67     98.1     149
780536 -    060711.......... 172  87     54     97.5     147
780537 -    060623.......... 141  87     71     98.0     147
780538 -    060428.......... 129  73     80     99.4     149
780539 -    060217.......... 153  81     61     98.6     150
780540 -    050916.......... 120  80     80     98.5
780541 -
780542 -  *  Need vitals taken twice to verify atypical diagnostics.
780543 -
780544 -
780545 -
780546 -
7806 -

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

8103 -
8104 - 1110
810501 -  ..
810502 - Energy Normal Stable After Treatment Cetuximab Support Drugs
810503 -
810504 - Follow up ref SDS 28 F54N, ref SDS 26 F54N.
810506 -  ..
810507 - On 060724 diary side effects for cetuximab chemotherapy treatment on
810508 - clinical study drug trial. ref SDS 6 YP4I
810510 -  ..
810511 - Millie was alert after treatment again today, and not wobbly nor
810512 - disoriented.  She was able to drive home without side effects of
810513 - treatment.
810514 -
810515 -
810516 -
810517 -
810518 -
810519 -
810520 -
810521 -
810522 -
8106 -