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: May 10, 2007 08:00 AM Thursday; Rod Welch

Millie at UCSF 3rd treatment 4th cycle cetuximab for 3rd relapse IBC.

1...Summary/Objective
2...Clinic Examination Orientation Starting Treatment Cetuximab
3...Schedule 8 Weeks Treatments for Next 2 Cycles Cetuximab Clinical Study
4...Breast Examination IBC Intensity Declines
5...NEUTS Blood Counts 1.54 Requires No Follow Up Test for Safe Treatment
6...CT Test Schedule on 8 Week Interval Test for Lung Heart Disorders
7...CT Test Scope Discover Severity Pulmonary Embolism Unnecessary
8...Emotional Roller Coaster Endemic Cancer Treatment and Coordination
9...Cetuximab Prognosis IBC May Subside for 10 Months Before Progressing
10...Prognosis Disease May Subside 10 Months or More Before Progression
11...Progresssion of Disease May be Delayed for 10 Months or More
12...10 Months or More Before Progresssion of Disease Switch to Gemzar
13...Gemzar Switched from Cetuximab Carboplatin 10 Months Progression
14...Side Effects Medicated After Weekly Examinations
15...Infusion Clinic for Cetuximab Treatent
..........Taxotere Capecitabine
..........Cetuxiab Clinical Study
16...Nurses Notes...
17...Side Effects Minimal...
........1...Rash acne-like
........2...Dry skin face, chest arm
........3...Lymphedema Cellulitis Complications
............Inflammation Erratic Upper Left Arm Side Effects Cetuximab
........4...Tired, fatigued - pulmonary emoblism
........5...Heavy chest - shortness of breathing
........6...Cough - clearing throat
18...Schedule Weekly Treatments Continue on Thursdays
19...Preparation for Treatment Required One (1. Attempt to Connect Port
20...Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
21...Cetuximab Full Dose Blood Counts Below Targets Treatment 1 Hour
22...Vitals Show Patient Stable
23...Energy Normal Stable After Treatment Cetuximab Support Drugs


..............
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CONTACTS 

SUBJECTS
Examination Treatment Cetuximab 3rd Treatment 4th Cycle Chemotherapy

1103 -
1103 -    ..
1104 - Summary/Objective
1105 -
110501 - Follow up ref SDS 75 0000. ref SDS 73 0000.
110502 -
110503 - Millie received the 3rd treatment starting the 4th cycle of cetuximab
110504 - chemotherapy on clinical study at UCSF. ref SDS 0 7T3H  Examination
110505 - shows continuing improvement with IBC rash subsiding. ref SDS 0 FO6H
110506 - Side effects remain mild. ref SDS 0 QU8K  UCSF scheduled meetings and
110507 - treatment for the next 2 cycles through 070802. ref SDS 0 3E8L  UCSF
110508 - decided testing blood counts for safe treatment was unnecessary.
110509 - ref SDS 0 MZ3N  UCSF took the initiative to schedule the next CT test
110510 - for the clinical study. ref SDS 0 DT8I  Somehow the test was scheduled
110511 - sooner than the 8 week interval specified by UCSF.  This was left
110512 - uncorrected. ref SDS 0 V36R  UCSF explained that previous thin slice
110513 - spiral CT test methods that discovered lung and heart disorders are
110514 - not needed to assess interim effect of treatment on preconditions.
110515 - ref SDS 0 VP4H  Patient emotional condition stabalized by favorable
110516 - response to treatment. ref SDS 0 6A7J  Millie has been treated with
110517 - cetuximab alone longer than other patients, further indicating strong
110518 - response and favorable prognosis. ref SDS 0 6A9H
110519 -
110520 -
110521 -
110523 -  ..
1106 -
1107 -
1108 - Progress
1109 -
110901 - Clinic Examination Orientation Starting Treatment Cetuximab
110902 -
110903 - Follow up ref SDS 75 407N, ref SDS 73 407N.
110905 -  ..
110906 - Agenda...
110907 -
110908 -    1.  Schedule meetings......................... ref SDS 0 9L9N
110909 -    2.  Breast examination........................ ref SDS 0 FO6H
110910 -    3.  Test blood counts NEUTS 1.54.............. ref SDS 0 MZ3N
110911 -    4.  CT test schedule 8 week intervals......... ref SDS 0 DT8I
110912 -    5.  Emotional coping with cancer.............. ref SDS 0 6A7J
110913 -    6.  Prognosis good............................ ref SDS 0 6A9H
110914 -    7.  Infusion Clinic........................... ref SDS 0 1M6H
110915 -    8.  Side effects.............................. ref SDS 0 QU8K
110916 -    9.  Schedule treatments....................... ref SDS 0 QK6L
110917 -   10.  Treatment cetuximab....................... ref SDS 0 4N5M
110918 -   11.  Vitals.................................... ref SDS 0 AW4L
110919 -   12.  Energy after treatment.................... ref SDS 0 F54N
110920 -
110921 -
110923 -  ..
110924 - Schedule 8 Weeks Treatments for Next 2 Cycles Cetuximab Clinical Study
110925 -
110926 - Follow up ref SDS 57 MQ3M.
110927 -
110928 - Millie asked about scheduling meetings for the next few months.  The
110929 - last treatment currently scheduled is in 2 weeks on 070524, shown in
110930 - the record on 070315. ref SDS 57 NM4M   At that time, Jackie explained
110931 - a new procedure for patients to work with scheduling assistants, who
110932 - then contact the doctors and nurses to plan the schedule and enter
110933 - everything in the computer. ref SDS 57 MQ3M
110935 -  ..
110936 - Brigid said the next few months will be difficult scheduling.  The
110937 - doctor's schedule is hectic.  Brigid will be on leave during June for
110938 - military reserve duty.  She checked the computer, and noted that
110939 - everyone's schedule seems full.  She explained that UCSF can schedule
110940 - meetings to fit Millie's weekly treatment cycle, explained on 070201,
110941 - ref SDS 38 DQ3F, and UCSF will assign someone to perform examinations
110942 - when they occur.  Brigid filled out a document.  After the meeting,
110943 - Millie met with the scheduling assistant at the front desk in the
110944 - lobby and submitted Bridig's order for scheduling treatment covering
110945 - the 8-week period after 070524.
110947 -  ..
110948 - The attendant reviewed Brigid's document and checked the computer.
110949 - She left the area for about 15 minutes to consult with Brigid and
110950 - others on the schedule.  She returned and said there are problems with
110951 - the schedule, but that UCSF will schedule meetings without knowing at
110952 - this time who will meet with Millie.
110954 -  ..
110955 - The new schedule for meetings is listed below, integrated with the
110956 - schedule from the Infusion Clinic for additional treatments.
110957 - ref SDS 0 QK6L
110958 -
110959 -
110960 -
110961 -
110962 -
110963 -
1110 -

SUBJECTS
Breast Examination Shows Improvement IBC Rash Intensity Subsides No

1903 -
190401 -  ..
190402 - Breast Examination IBC Intensity Declines
190403 -
190404 - Follow up ref SDS 75 FO6H, ref SDS 73 FO6H.
190405 -
190406 - Examination today shows continuing favorable recovery from 3rd relapse
190407 - of IBC with treatment using cetuximab alone, reported on 070426.
190408 - ref SDS 72 LB5L
190409 -
190410 -
190411 -
190412 -
190413 -
1905 -

SUBJECTS
Blood Tests Schedule Evaluate Blood Counts ANC NEUTS High Enough Saf

3303 -
330401 -  ..
330402 - NEUTS Blood Counts 1.54 Requires No Follow Up Test for Safe Treatment
330403 -
330404 - Brigid said that UCSF received Millie's letter, ref DIP 1 TV4H,
330405 - submitted yesterday on 070509, ref SDS 76 3N4W, and asking about
330406 - follow up tests on blood counts that dropped dramatically 2 weeks ago
330407 - on 070426, ref SDS 73 P560, and then rose slightly last week on
330408 - 070503, but are still well below the level UCSF lists for safe
330409 - treatments. ref SDS 75 P560
330410 -
330411 -
330412 -
330413 -
3305 -

SUBJECTS
CT Scan Test Scheduled 070514 Not Enough Time Respond Patient Reques

4503 -
450401 -  ..
450402 - CT Test Schedule on 8 Week Interval Test for Lung Heart Disorders
450403 -
450404 - Follow up ref SDS 76 3M6V, ref SDS 62 DA8O.
450405 -
450406 - Brigid discussed Millie's letter, ref DIP 1 T76N, yesterday on 070509,
450407 - and reporting notice that Kaiser has scheduled a CT test on 070514.
450408 - ref SDS 76 3M6V
450410 -  ..
450411 - Jackie advised that she coordinated with Kaiser to schedule a CT test
450412 - required by the clincial study protocol.
450413 -
450414 -        [On 070610 primary care physician advises channels of
450415 -        communication now established with UCSF for referral case
450416 -        management. ref SDS 83 GV9G
450418 -  ..
450419 - UCSF performing case management is a big help to Millie, discussed
450420 - further below on relieving patient stress. ref SDS 0 M29K
450422 -  ..
450423 - Discussion on 070301 indicated UCSF saves time relying on patients to
450424 - coordinate work with referring physicians. ref SDS 46 O67N  At that
450425 - time, on 070301, Brigid suggested that Millie schedule a CT test at
450426 - Kaiser. ref SDS 46 CI9L  Millie coordinated on 070307, ref SDS 51
450427 - 9Z9N, and on 070309, Kaiser scheduled a CT test for 070328.
450428 - ref SDS 55 VP5N  Kaiser's schedule conflicted with Brigid's order for
450429 - testing to accomodate Doctor Rugo's schedule.  Millie followed up to
450430 - align Kaiser's work with UCSF requirements, reported in a letter on
450431 - 070314. ref SDS 56 DT4I  Case study on 070307 shows coordination took
450432 - a lot of work, ref SDS 51 G56L, discussed with the medical team at
450433 - UCSF on 070315. ref SDS 57 OG6G
450435 -  ..
450436 - Jackie noted irony of Kaiser scheduling the prior test too late, and
450437 - now scheduling the next CT test on 070514, about 2 weeks earlier than
450438 - requirements of the cetuximab clinical study to test every 8 weeks.
450440 -  ..
450441 - There wasn't enough time during the meeting today for UCSF to submit
450442 - requirements for 8 week testing, discussed in Millie's letter
450443 - yesterday on 070509. ref SDS 76 3N3V
450445 -  ..
450446 - Brigid explained that trauma to the patient from frequent CT tests
450447 - noted in Millie's letter yesterday, ref SDS 76 3N3V, is hard to
450448 - relieve in this case.  Since Kaiser has already scheduled the test on
450449 - 070514, getting this changed to align with UCSF requirements takes a
450450 - lot of work, shown by case study on 070307 presenting Millie's
450451 - experience coordinating work at Kaiser. ref SDS 51 G56L
450452 -
450453 -     [On 070511 Kaiser called Millie to advise that additional blood
450454 -     tests needed for the CT test; Millie explained requirements of the
450455 -     cetuximab clinical study for CT testing on 8 week cycles; Kaiser
450456 -     changed the test date from 070514 to 070520 to better align with
450457 -     UCSF requirements. ref SDS 77 T77M
450459 -      ..
450460 -     [On 070516 Millie notified UCSF schedule changed to meet
450461 -     requirements of clinical study, and reduce trauma to patient from
450462 -     frequent testing. ref SDS 79 EF9M
450463 -
450464 -
450465 -
450466 -
450467 -
4505 -

SUBJECTS
CT Test Scope Schedule 4th Cycle UCSF Clinical Study Cetuximab Asses

6103 -
610401 -  ..
610402 - CT Test Scope Discover Severity Pulmonary Embolism Unnecessary
610403 -
610404 - Follow up ref SDS 76 XR6G.
610405 -
610406 - Brigid discussed evaluation of Millie's pulmonary embolism and Cor
610407 - Pulmonale using thin slice spiral CT technology, which was omitted
610408 - from the last test on 070326, as reported in the record meeting at
610409 - UCSF on 070329, ref SDS 61 0136, and presented in Millie's letter
610410 - yesterday. ref SDS 76 EQ9O
610412 -  ..
610413 - Brigid indicated that UCSF standard of care on the cetuximab clinical
610414 - study does not require notifying Kaiser to use thin slice spiral CT
610415 - technology for the test scheduled for 070517, and in order to increase
610416 - scrutiney 500% from 5 mm scans to 1 mm scans for evaluating presence
610417 - of lung and heart disorders.  This issue was discussed during the
610418 - meeting with Doctor Rugo on 070130.  At that time, UCSF planned
610419 - vigorous testing to manage risks of complications and compounding
610420 - preconditions. ref SDS 36 RS9O  Thin slice spiral CT testing had been
610421 - effective in Millie's case. ref SDS 36 E17H
610423 -  ..
610424 - Today, Brigid seemed to indicate that until pulmonary embolism and Cor
610425 - Pulmonale advance to a point of visibility in CT tests without thin
610426 - slice spiral CT technology the patient has nothing to worry about, and
610427 - can safely continue on the cetuximab clincial study drug trial with
610428 - documented cases of pulmonary embolism and heart disorders, reported
610429 - in the Consent documents received from UCSF on 070116. ref SDS 35 I75I
610430 - Brigid noted UCSF is not worried about Millie being at risk, because,
610431 - so far, standard of care without thin slice spiral CT technology has
610432 - been effective treating other patients at UCSF on the cetuximab
610433 - carbopltin clincial study.
610435 -  ..
610436 - On 070201 UCSF advised there are six (6) patients in the cetuximab
610437 - carboplatin clincial study at UCSF. ref SDS 38 G68L  Millie's patient
610438 - history may be different, illustrated by Jackie's report this morning
610439 - that Millie has responded well to treatment with cetuximab alone
610440 - longer than other patients in the study, per below. ref SDS 0 YF74
610442 -  ..
610443 - Case study on 060722 shows Millie had many CT tests in 2004 in the
610444 - form UCSF proposes today.  None showed pulmonary embolism; yet,
610445 - symptoms increased over many months. ref SDS 18 6G6O  Like today at
610446 - UCSF, ref SDS 0 KD5I, on 041005 Kaiser told Millie not to worry about
610447 - continuing treatment with the Taxol and bevacizumab (Avastin) clinical
610448 - trial, ref SDS 7 RZ4I, which, like cetuximab and carboplatin, reported
610449 - on 070116, ref SDS 35 I75I, had a few cases of death from pulmonary
610450 - embolism, reported on 040812. ref SDS 6 MG4G  At that time, Kaiser
610451 - presented Millie with a dilemma of rising symptoms without explanation
610452 - by testing nor resolution with treatment, and continuing treatment for
610453 - cancer, which, like cetuximab, was effective, but presented risks of
610454 - lung and heart disorders.
610455 -
610456 -     [On 070517 patient history showing only thin slice spiral CT
610457 -     testing has identified lung and heart disorders in Millie's case
610458 -     shows specifying testing that has been effective for Millie does
610459 -     not require the same level of investigation for patients with
610460 -     different patient history. ref SDS 80 WX91
610462 -  ..
610463 - Millie resolved the dilemma by getting a 2nd opinion from UCSF, also,
610464 - reported on 041005. ref SDS 7 OG5L  On 041018 Millie presented the
610465 - issue to Doctor Benz. ref SDS 8 LX96  The doctor explained that
610466 - serious cardiopulmonary disorders can form which busy analysts
610467 - overlook using conventional imaging technology. ref SDS 8 588O  Two
610468 - weeks later, Kaiser scheduled an exigent test on 041103.  The next day
610469 - on 041104 the doctor advised that Millie was diagnosed with pulmonary
610470 - embolism.  Millie was removed from treatment with Taxol bevacizumab
610471 - (Avastin) drug trial. ref SDS 9 RZ4I  Kaiser advised on 041104 that
610472 - blood clots on the lungs, overlooked in previous CT tests, were
610473 - causing symptoms for 6 months, which, if not relieved by immediate
610474 - action, could cause death, ref SDS 9 N43I, and therefore, would
610475 - require disruptive monitoring and treatment for the rest of Millie's
610476 - life. ref SDS 9 4Y9G  Discussion today, seems to indicate this was
610477 - unnecessary overkill because problems discovered on 041103 were not
610478 - identified using CT tests without thin slice spiral CT technology.
610479 - ref SDS 0 KD5I
610481 -  ..
610482 - Millie had another thin slice spiral CT test on 041217.  Kaiser
610483 - reported on 041230 that the test showed the prior condition found on
610484 - 041103 was resolved by treatment. ref SDS 12 PW3K  A year later, after
610485 - many additional tests showed no findings of pulmonary embolism, on
610486 - 051007 Kaiser ended Millie's treatment for pulmonary embolism.
610487 - ref SDS 14 RZ4I  Another year later, after continuing CT tests
610488 - reported no findings of pulmonary embolism, on 060929 Millie
610489 - complained of symptoms. ref SDS 24 B56N  Kaiser performed an exigent
610490 - test the next day on 060930. ref SDS 26 MI5I  On 061002 the doctor
610491 - called and reported the test diagnosed recurrance of pulmonary
610492 - embolism. ref SDS 27 MI5I  Immediate same day treatment was prescribed
610493 - for Millie. ref SDS 27 JK7J
610495 -  ..
610496 - On 061012 Kaiser's report on the test presented findings of enlarged
610497 - right ventricle, ref SDS 28 7E5L, which was not noted in the doctor's
610498 - call on 061002.  Research on 061012 indicates Cor Pulmonale describes
610499 - enlarged right ventricle, and can be caused by pulmonary embolism,
610500 - leading to death. ref SDS 28 L35J  Kaiser's letter submitted by the
610501 - primary care physician on 061228 noted that Millie's Cor Pulmonale may
610502 - have been caused by pulmonary embolism. ref SDS 34 0M6O
610504 -  ..
610505 - On 061020 Kaiser disclosed that CT tests for pulmonary embolism on
610506 - 041103, the follow up on 041218, and the recent test that reported
610507 - recurrence used thin slice spiral technology, ref SDS 30 S56G, which
610508 - is more comprehensive than the other CT tests Millie had which did not
610509 - show lung and heart disorders.
610511 -  ..
610512 - Brigid noted that Millie has no evident symptoms, as occurred with
610513 - prior testing for pulmonary embolism in 2004, and 2006.  Why should
610514 - UCSF recommend Kaiser investigate again with thin slice spiral CT
610515 - testing, as discussed with Doctor Benz on 041018, when currently there
610516 - are no symptoms?  Millie seems healthy today, and has been playing
610517 - tennis, hiking, working out in the gym.  This makes testing for
610518 - cardiopulmonary disorders seem like unnecessary overkill.
610520 -  ..
610521 - Research on 060722 indicated 45% of people who suffer recurrent
610522 - pulmonary embolism suddenly die without any symptoms. ref SDS 18 BI5J
610523 - Research on 061012 further notes that often there are no symptoms of
610524 - Cor Pulmonale until the patient dies. ref SDS 28 LG9L
610526 -  ..
610527 - An example occurred recently while hiking at Lafayette Park.  About 2
610528 - miles along the trail, several emergency vehicles were assembled with
610529 - lights flashing, and attendants conferring.  This was extremely
610530 - alarming, because the trail is quite narrow and remote.  Manuevering
610531 - ambulances, Fire Trucks, and other vehicles bringing assistance was
610532 - difficult and disrupting.  Inquiry among hikers, who saw the incident,
610533 - revealed that an elderly couple were going up one of the steeper
610534 - hills, and the man, perhaps younger than Millie, simply keeled over,
610535 - totally without warning or complaining of symptoms, as noted in
610536 - research. ref SDS 0 AL3K  This person's medical history, and
610537 - disposition are not known.  However, Millie's patient history and
610538 - family history of cardiopulmonary disorders is well known.  Managing
610539 - Millie's disposition requires testing to guide action based on her
610540 - history.
610542 -  ..
610543 - Since cetuximab places Millie at increased risk, per above,
610544 - ref SDS 0 KD5I, this requires increased review.  Since other methods
610545 - have proven ineffective, and since thin slice spiral CT tests have
610546 - proven effective identifying cardiopulmonary disease in Millie's case,
610547 - this method should be proposed by UCSF to meet study requirements.
610549 -  ..
610550 - UCSF's analysis today that lung and heart disease are not serious
610551 - enough for action until disease rises to a level identified by CT
610552 - testing without thin slice spiral CT technology suggests that Doctor
610553 - Benz recommendations in 2004 for Kaiser to investigate were erroneous,
610554 - since Kaiser had already performed such tests and found nothing.
610555 - ref SDS 0 HW5I  Under the UCSF criteria today, findings on 041104
610556 - should have been ignored; Millie should have continued treatment on
610557 - the drug trial for Taxol and bevacizumab (Avastin), and proactive case
610558 - management involving years of treatment for pulmonary embolism have
610559 - been a wasteful mistake, i.e., unnecessary overkill.
610561 -  ..
610562 - Brigid explained that getting Kaiser to align work with requirements
610563 - takes extra time, is difficult and stressful, shown by case study of
610564 - prodigious efforts by Doctor Rugo, Jackie, and others to get Millie
610565 - treated on referral from Kaiser. ref SDS 37 RM4G  It's a lot faster
610566 - and easier to interpret requirements as suggestions that are
610567 - unnecessary overkill, discussed above. ref SDS 0 VP4H
610568 -
610569 -     [On 070514 Millie coordinated with Kaiser to align CT testing with
610570 -     requirements for evaluating preconditions pulmonary embolism and
610571 -     Cor Pulmonale that can become complications from treatments on the
610572 -     cetuximab clinical study. ref SDS 78 IM9O
610574 -  ..
610575 - NASA reported to Congress on 030826 that small problems compound into
610576 - conflict and calamity, because people interpret requirements as
610577 - suggestions, which can be ignored in order to avoid performing work,
610578 - ref SDS 4 8K4G, that can sometimes seem unpleasant and stressful, like
610579 - writing a letter explaining requirements for further investigation, as
610580 - UCSF did on 041018, ref SDS 0 KD84, and which resulted in changing
610581 - the course of care to align with patient history.
610582 -
610583 -     [On 070516 Kaiser discloses all CT scans are thin slice spiral
610584 -     technology; Kaiser chooses to review and analyse test data at
610585 -     different intervals; and since 061030, Kaiser has refused to
610586 -     assess Millie's lung and heart disorders. ref SDS 79 SE4L
610588 -      ..
610589 -     [On 070516 Millie coordinated with Kaiser to perform requirements
610590 -     of clincial study for monitoring lung and heart preconditions by
610591 -     comparing next CT test on 070520 with prior testing that diagnosed
610592 -     pulmonary embolism and enlarged right ventricle (Cor Pulmonale)
610593 -     for trend analysis. ref SDS 79 Y76G
610595 -      ..
610596 -     [On 070517 Kaiser discloses that costs do not justify benefits of
610597 -     performing clincial study requirements to monitor Millie's
610598 -     preconditions of lung and heart disorders in order to guide
610599 -     treatment decisions on saving lives, time, and money. ref SDS 80
610600 -     OS5G
610601 -
610602 -
610603 -
610604 -
6107 -

SUBJECTS
Emotional Trauma Stress Moderate Pulse Normal Cancer Subsides Reliev

7003 -
700401 -  ..
700402 - Emotional Roller Coaster Endemic Cancer Treatment and Coordination
700403 -
700404 - Follow up ref SDS 75 6A7J, ref SDS 73 6A7J.
700405 -
700406 - Brigid asked about coping emotionally with cancer and demands of
700407 - getting treatments on the clinical study, following up discussions on
700408 - 070315? ref SDS 57 6A7J  This issue was discussed more recently on
700409 - 070426 citing improved prognosis. ref SDS 72 Y642
700411 -  ..
700412 - UCSF recent practice providing timely, accurate communication with
700413 - email on evolving medical conditions, shown by Brigid's letter on
700414 - 070501, ref SDS 74 EQ6I, strengthens coordination through team care
700415 - discussed previously on 070301. ref SDS 46 O67N  The doctor patient
700416 - partnership model increases health care effectivness, called out in
700417 - the Kaiser Healthwise Handbook, reviewed on 990625. ref SDS 1 4185
700418 - Better communication helps reduce stress by relieving worry and doubt
700419 - about medical mistakes, reviewed on 990912. ref SDS 2 0001  Using
700420 - email for timely, accurate communication on 070501 may therefore help
700421 - correct problems on 070329 ignoring patient history on side effects.
700422 - ref SDS 61 W25L
700423 -
700424 -        [On 070524 rising cancer marker, and new communication problems
700425 -        preventing collaboration between Kaiser and UCSF increase
700426 -        emotional stress. ref SDS 81 Y642
700428 -         ..
700429 -        [On 070607 sudden attack of Lymphedema compounded by Cellulitis
700430 -        require emergency care cause emotional stress to accelerate
700431 -        like a roller coaster. ref SDS 82 6A7J
700433 -  ..
700434 - Good news of medical improvement reported two (2) weeks ago on 070426,
700435 - ref SDS 72 Y642, relieves stress.  Brigid's letter on 070501 with
700436 - favorable test results for CA 15-3 29, ref SDS 74 EQ6I, cited in the
700437 - letter to UCSF yesterday on 070509, ref SDS 76 KR6K, helps relieve
700438 - stress from worry and doubt about the future.
700440 -  ..
700441 - Good news today that Millie has responded longer with cetuximab alone
700442 - than other patients relieves stress with hope of a longer, productive
700443 - life, per below. ref SDS 0 6A9H
700445 -  ..
700446 - UCSF taking the initiative to coordinate with Kaiser scheduling the
700447 - next CT test relieves a great deal of stress, per above. ref SDS 0
700448 - DT8I  Increasing frequency of testing to six weeks well in advance of
700449 - study requirements increases stress contemplating physical trauma
700450 - enduring the test process, as noted in Millie letter to UCSF
700451 - yesterday. ref SDS 76 3N3V  UCSF avoiding time, effort, and stress
700452 - correcting Kaiser scheduling mistakes to align with requirements,
700453 - ref SDS 0 V36R, increases patient stress performing case management to
700454 - align Kaiser's work with requirements.
700456 -  ..
700457 - Relief from emotional trauma is tempered by rising stress from complex
700458 - communications coordinating referral illustrated by examples listed on
700459 - 070315. ref SDS 57 OR5K  Difficulty getting good people to use good
700460 - management performing test study requirements that align with patient
700461 - history, discussed above, ref SDS 0 TK8H, increases worry and doubt
700462 - about the future, also, illustrated by example presented above.
700463 - ref SDS 0 AL3K
700464 -
700465 -
700466 -
7005 -

SUBJECTS
Prognosis Stable Low Intensity IBC Rash Remarkable Response Treatmen

7903 -
790401 -  ..
790402 - Cetuximab Prognosis IBC May Subside for 10 Months Before Progressing
790403 - Prognosis Disease May Subside 10 Months or More Before Progression
790404 - Progresssion of Disease May be Delayed for 10 Months or More
790405 - 10 Months or More Before Progresssion of Disease Switch to Gemzar
790406 -
790407 - Follow up ref SDS 75 6A9H, ref SDS 73 6A9H.
790409 -  ..
790410 - Brigid seemed to indicate Millie's favorable response to treatment
790411 - with cetuximab alone is remarkable and unexpected in relation to
790412 - experience on the clinical study.
790414 -  ..
790415 - Jackie reported that Millie has been treated with cetuximab longer
790416 - than other patients in the clinical trial.  Usually after a few weeks
790417 - or months, disease progresses, requiring UCSF to upgrade treatment by
790418 - adding carboplatin.  This was considered in Millie's case on 070301,
790419 - but a week later on 070308 falling cancer marker supported impression
790420 - from examinations that IBC rash is subsiding.  This resulted in
790421 - continuing treatment with cetuximab alone. ref SDS 52 YA6O
790423 -  ..
790424 - Favorable response to treatment naturally relieves stress, reported
790425 - above. ref SDS 0 TL3M  Differences responding to treatment in Millie's
790426 - case supports consideration for testing that aligns with patient
790427 - history, also discussed above. ref SDS 0 AL48
790428 -
790429 -
790430 -
790431 -
7905 -

SUBJECTS
Cetuximab Prognosis IBC Subside 10 Months Before Progressing Woman S

8703 -
870401 -  ..
870402 - Gemzar Switched from Cetuximab Carboplatin 10 Months Progression
870403 -
870404 - Millie asked how the woman is doing who was treated for 10 months on
870405 - cetuximab and carboplatin, reported on 070315? ref SDS 57 6A40
870407 -  ..
870408 - Brigid advised that this patient later suffered progression of
870409 - disease, and is now being treated with Gemzar.  On 061201 Kaiser
870410 - proposed switching Millie to Gemzar or Navelbine, ref SDS 33 ZZ9N.
870411 - Gemzar in combination with Taxotere was presented in a 2nd opinion
870412 - received from Doctor Benz on 041117, ref SDS 10 OU6S, following
870413 - consultation at UCSF on 041018.  Later, in a follow up 2nd opinion
870414 - received on 060929 Doctor Benz discussed Navelbine and Gemzar in
870415 - combination with capeticabine. ref SDS 25 WR3Y
870416 -
870417 -
8705 -

SUBJECTS
Side Effects Cetuximab Acne-like Rash Face Dry Skin Face Chest Arms

9303 -
930401 -  ..
930402 - Side Effects Medicated After Weekly Examinations
930403 -
930404 - Follow up ref SDS 75 FO66, ref SDS 73 FO66.
930405 -
930406 - Side Effects were considered carefully by Brigid during examination
930407 - this morning, and again during treatment in the Infusion Clinic,
930408 - reported below. ref SDS 0 QU8K
930409 -
930410 -
930411 -
930412 -
9305 -

SUBJECTS
Cetuximab 4th Cycle 3rd Treatment 15th Total Treatment Chemotherapy

9903 -
9904 - 0845
990501 -  ..
990502 - Infusion Clinic for Cetuximab Treatent
990503 -
990504 - Follow up ref SDS 75 1M6H, ref SDS 73 1M6H.
990506 -  ..
990507 - Millie received 15th overall and 3rd treatment of 4th cycle with
990508 - cetuximab, starting from 070201, ref SDS 38 G68I, and the 22nd
990509 - treatment for 3rd relapse of IBC, beginning on 060721. ref SDS 17 407N
990511 -  ..
990512 - Catherine was the nurse today.
990514 -           ..
990515 -          Taxotere Capecitabine
990516 -
990517 -          Follow up ref SDS 75 PR8Q, ref SDS 73 PR8Q.
990518 -
990519 -                   Relapse Treatments
990520 -
990521 -      1.  Cycle 09 and 01 ................... 060721, ref SDS 17 407N
990522 -      2.  Cycle 10 and 02 ................... 060814, ref SDS 21 LY6O
990523 -      3.  Cycle 11 and 03 ................... 060908, ref SDS 22 407N
990524 -      4.  Cycle 12 and 04 ................... 060929, ref SDS 23 407N
990525 -      5.  Cycle 13 and 05 ................... 061020, ref SDS 29 407N
990526 -      6.  Cycle 14 and 06 ................... 061110, ref SDS 31 407N
990527 -      7.  Cycle 15 and 07 ................... 061201, ref SDS 32 407N
990529 -           ..
990530 -          Cetuxiab Clinical Study
990531 -
990532 -          Follow up ref SDS 75 7T3H, ref SDS 73 7T3H.
990533 -
990534 -                   Total    Cetuximab
990535 -      8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 38 SG8I
990536 -      9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 40 SG8I
990537 -     10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 41 SG8I
990538 -     11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 44 SG8I
990539 -     12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 49 SG8I
990540 -     13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 52 7T3H
990541 -     14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 57 7T3H
990542 -     15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 58 7T3H
990543 -     16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 63 7T3H
990544 -     17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 66 7T3H
990545 -     18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 68 7T3H
990546 -     19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 70 7T3H
990547 -     20.  Cycle 04 and 11 and 01 13.......... 070426, ref SDS 73 7T3H
990548 -     21.  Cycle 04 and 11 and 02 14.......... 070503, ref SDS 75 7T3H
990549 -     22.  Cycle 04 and 11 and 03 15.......... 070510, ref SDS 0 7T3H
990551 -  ..
990552 - Nurses Notes...
990563 -  ..
990564 - Why is the visit number constant in Nurse's Notes, and yet seems to
990565 - vary in the schedule received from Nola last week? ref SDS 57 159O
990567 -     ..
990568 -    UCSF Log Time...
990569 -
990570 -                   Blood
990571 -                    Test   Infusion
990572 -
990573 -          In.......          0830
990574 -          Out......          1130
990575 -          Visit....      Min  3.0  Hours  Total 3 Hours
990577 -      ..
990578 -     Pain Assessment...
990579 -
990580 -          x
990581 -          0123456789 10
990582 -
990583 -     <923k
990584 -     Administration Site:  Right Port Catheter
990585 -     Needle Size:          20 G 1"
990586 -     Blood Return Good:    Yes
990588 -      ..
990589 -     Remind patient to call MD if temp > 101 F, Shaking Chills
990590 -
990591 -            This protocol differs from Kaiser requirements, reported on
990592 -            041202. ref SDS 11 IX9N
990593 -
990594 -
990595 -
990596 -
9906 -

SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A

AH03 -
AH04 - 0840
AH0501 -  ..
AH0502 - Side Effects Minimal...
AH0503 -
AH0504 - Follow up ref SDS 75 QU8K, ref SDS 73 QU8K.
AH0506 -  ..
AH0507 - Nurse's notes report side effects...
AH0509 -             ..
AH0510 -        1.  Rash acne-like
AH0511 -
AH0512 -            Follow up ref SDS 75 SK9O, ref SDS 73 SK9O.
AH0513 -
AH0514 -            Very mild facial rash continues from 070208 around the nose
AH0515 -            and chin. ref SDS 40 QU8K  Treatment effective prescribed
AH0516 -            on 070222. ref SDS 44 FO66
AH0517 -
AH0519 -             ..
AH0520 -        2.  Dry skin face, chest arm
AH0521 -
AH0522 -            Follow up ref SDS 75 JS6M, ref SDS 73 JS6M.
AH0523 -
AH0524 -            Background reported on 070503. ref SDS 70 JS6M  Condition
AH0525 -            continues controlled with Curel treatment prescribe on
AH0526 -            070301, ref SDS 46 5V73, and later Aquaphor on 070322.
AH0527 -            ref SDS 58 JS6M
AH0528 -
AH0530 -             ..
AH0531 -        3.  Lymphedema Cellulitis Complications
AH0532 -            Inflammation Erratic Upper Left Arm Side Effects Cetuximab
AH0533 -
AH0534 -            Follow up ref SDS 75 SU6L, ref SDS 73 SU6L.
AH0535 -
AH0536 -            Lymphedema continues relatively controlled with major
AH0537 -            swelling in the left reduced this morning to 10.75, cited
AH0538 -            in the study on 060509. ref SDS 15 HO7F  There is no evident
AH0539 -            association with cetuximab treatments.
AH0541 -             ..
AH0542 -            Intensity of rash on the upper left arm continues to rise
AH0543 -            and fall since the report at Kaiser on 070330. ref SDS 65
AH0544 -            N19J Causes of erratic inflammation are listed in the
AH0545 -            record for treatment last week on 070426. ref SDS 73 8B8Y
AH0547 -             ..
AH0548 -            Today, there is no evidence of increased inflammation on
AH0549 -            the upper left arm, continuing favorable report for
AH0550 -            examination last week on 070503, ref SDS 75 8B8I, and
AH0551 -            previously by the medical team on 070426. ref SDS 72 115F
AH0552 -
AH0554 -             ..
AH0555 -        4.  Tired, fatigued - pulmonary emoblism
AH0556 -
AH0557 -            Follow up ref SDS 75 FG3N, ref SDS 73 FG3N.
AH0558 -
AH0559 -            Fatigue, shortness of breath and other symptoms of
AH0560 -            pulmonary embolism were presented during meeting on 070130,
AH0561 -            ref SDS 36 CV5L, citing case study listed on 060722.
AH0562 -            ref SDS 18 ZV41  These are also side effects of cetuximab
AH0563 -            treatments, reported on 070116. ref SDS 35 O64M  Planning
AH0564 -            was discussed this morning with the medical team for thin
AH0565 -            slice spiral CT test to assess pulmonary embolism and Cor
AH0566 -            Pulmonale (enlarged right ventricle), per above.
AH0567 -            ref SDS 0 VP4H
AH0569 -             ..
AH0570 -            Energy and exercise remain active, reported on 070503.
AH0571 -            ref SDS 75 CA4K
AH0573 -             ..
AH0574 -            Millie has been taking naps 2 - 3 hours after treatments
AH0575 -            the past month, beginning on 070405. ref SDS 66 BB7G  May
AH0576 -            indicate accumulating effects of cetuximab that make
AH0577 -            patients tired, listed as side effect in Consent documents
AH0578 -            reviewed on 070116. ref SDS 35 O64M
AH0579 -
AH0581 -             ..
AH0582 -        5.  Heavy chest - shortness of breathing
AH0583 -
AH0584 -            Follow up ref SDS 70 UL6L
AH0585 -
AH0586 -            Patient history was reported to UCSF on 070130. ref SDS 36
AH0587 -            RT6I
AH0589 -             ..
AH0590 -            Condition seems improved, tracking continuing higher
AH0591 -            energy, per above. ref SDS 0 CA4K
AH0592 -
AH0594 -             ..
AH0595 -        6.  Cough - clearing throat
AH0596 -
AH0597 -            Follow up ref SDS 70 8N4G
AH0598 -
AH0599 -            Condition seems less evident lately.
AH0600 -
AH0601 -
AH0602 -
AH0603 -
AH07 -

SUBJECTS
Schedule Treatment Weekly Thursday 0830 4 Week Cycles Clinical Study

AP03 -
AP0401 -  ..
AP0402 - Schedule Weekly Treatments Continue on Thursdays
AP0403 -
AP0404 - Follow up ref SDS 75 QK6L, ref SDS 73 QK6L.
AP0406 -  ..
AP0407 - Millie's next treatment is scheduled for 070517 0830, reported by Nola
AP0408 - on 070315. ref SDS 57 159O
AP0410 -  ..
AP0411 - This morning, Millie asked Nola about scheduling treatments for the
AP0412 - next few months, per discussions with the medical team reported above.
AP0413 - ref SDS 0 9L9N  Nola checked the computer and submitted an updated
AP0414 - schedule that also shows meetings with the doctor for examinations...
AP0416 -     ..
AP0417 -    Date  Time  Staff      Sta Type Dept  Loc  Dur Number Cycl/Trmnt
AP0418 -    -----------------------------------------------------------------
AP0419 -    070531 0830  Catherine    PEN  P1H  CCINF  INF  60            05  02
AP0420 - ?  070607 0800  Brigid       PEN  CHF  BCC    Z4F  30  12997853  05  03
AP0421 -                 Jackie
AP0422 -    070607 0830  Catherine    PEN  P1H  CCINF  INF  60  12997886  05  03
AP0423 -    070614 0830  Catherine    PEN  P1H  CCINF  INF  60  12997890  05  04
AP0424 -    070621 0800  Doctor Rugo  PEN  CHF  BBC    Z4F  30  12997859  06  01
AP0425 -                 Mary Lou
AP0426 -                 Jackie
AP0427 -    070621 0830  Catherine    PEN  P1H  CCINF  INF  60  12997893  06  01
AP0428 -    070628 0830  Catherine    PEN  P1H  CCINF  INF  60  12997897  06  02
AP0429 - ?  070705 0800  Doctor Rugo  PEN  CHF  BCC    Z4F  30            06  03
AP0430 -                 Brigid
AP0431 -                 Jackie
AP0432 -    070705 0830  Catherine    PEN  P1H  CCINF  INF  60  12997900  06  03
AP0433 -    070712 0830  Catherine    PEN  P1H  CCINF  INF  60  12997902  06  04
AP0434 -    070719 0800  Doctor Rugo  PEN  CHF  BBC    Z4F  30  12997805  07  01
AP0435 -                 Brigid
AP0436 -                 Jackie
AP0437 -    070719 0830  Catherine    PEN  P1H  CCINF  INF  60  12997914  07  01
AP0438 -    070726 0830  Catherine    PEN  P1H  CCINF  INF  60  12997916  07  02
AP0439 - ?  070802 0830  Doctor Rugo  PEN  CHF  BCC    Z4F  30  12997818  07  03
AP0440 -                 Brigid (military duty)
AP0441 -                 Jackie
AP0442 -    070802 0900  Catherine    PEN  P1H  CCINF  INF  60  12997919  07  03
AP0444 -  ..
AP0445 - ?? Questions on the Schedule...
AP0446 -
AP0447 -        1.  Doctor Rugo is listed for meeting with Millie on 070607
AP0448 -            which is the 3rd treatment of the 5th cycle.
AP0449 -
AP0450 -            Normally, Doctor Rugo sees Millie only on the 1st
AP0451 -            treatment to start each new cycle.
AP0453 -             ..
AP0454 -        2.  No meeting is schedule for 070705 which is the 3rd
AP0455 -            treatment of the 6th cycle.
AP0457 -             ..
AP0458 -            UCSF has been meeting regularly with Millie for the 3rd
AP0459 -            cycle of treatments, as planned during the meeting on
AP0460 -            070201. ref SDS 38 DQ3F
AP0462 -             ..
AP0463 -        3.  Doctor Rugo is listed for meeting with Millie on 070802
AP0464 -            which is the 3rd treatment of the 7th cycle.
AP0466 -             ..
AP0467 -            Normally, Doctor Rugo sees Millie only on the 1st
AP0468 -            treatment to start each new cycle.
AP0469 -
AP0470 -
AP0471 -
AP0472 -
AP05 -

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

AX03 -
AX04 - 0845
AX0501 -  ..
AX0502 - Preparation for Treatment Required One (1. Attempt to Connect Port
AX0503 -
AX0504 - Follow up ref SDS 75 EB7J, ref SDS 73 EB7J.
AX0506 -  ..
AX0507 - The nurse connected the IV tubes to the port....
AX0509 -       ..
AX0510 -      Interlink System Vented Paclitaxel set
AX0512 -  ..
AX0513 - Like last week and earlier on 070301, there were no problems getting
AX0514 - blood to flow from the port, ref SDS 49 EB7J, as occurred on 070222,
AX0515 - ref SDS 43 DC5W, and earlier on 070201. ref SDS 38 DC5W
AX0517 -  ..
AX0518 - The nurse flushed the port with saline.
AX0520 -  ..
AX0521 - Prior inflammation above and at the port catheter penetration reported
AX0522 - on 070419, ref SDS 70 UJ4M, has improved, reported on 070503.
AX0523 - ref SDS 75 RQ4O
AX0524 -
AX0525 -
AX06 -

SUBJECTS
Benadryl Pre-treatment Prepares Patient for Cetuximab Chemotherapy A

B403 -
B404 - 0900
B40501 -  ..
B40502 - Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
B40503 -
B40504 - Follow up ref SDS 75 DC7J, ref SDS 73 DC7J.
B40505 -
B40506 - Benadryl (diphenhydramine) started.   25 MG....... ref SDS 73 IJ44
B40507 -
B40508 -        Purpose reported on 060721. ref SDS 16 DC7J
B40510 -  ..
B40511 - Chemotherpay order calls for Benadryl (diphenhydramine) pre-treatment
B40512 - 30 - 60 minutes prior to cetuximab infusion, shown below. ref SDS 0
B40513 - IJ41
B40514 -
B40515 -
B40517 -  ..
B406 -
B407 -
B408 - 0920
B409 -
B40901 - Benedryl completed equipment beeps.
B40902 -
B40903 -
B40904 -
B40906 -  ..
B410 -
B411 -
B412 -
B413 -
B41301 - Decadron (dexamethasone) IV pre-treatment........ ref SDS 58 FM4M
B41302 -
B41303 - On 070208 Decadron was not given because Millie did not experience
B41304 - side effects of nausea and vomitting after treatment with cetuximab on
B41305 - 070201. ref SDS 40 G57I  Since this favorable condition continues, per
B41306 - above, ref SDS 58 D19M, Decadron was not given again today.
B41307 -
B41309 -  ..
B414 -
B415 -
B416 -
B41601 - Decadron completed -- not reported.
B41602 -
B41603 -
B41604 -
B41605 -
B417 -

SUBJECTS
Cetuximab 4th Cycle 3rd Treatment Blood Counts Below Safe Levels Cli

BE03 -
BE04 - 0940
BE0501 -  ..
BE0502 - Cetuximab Full Dose Blood Counts Below Targets Treatment 1 Hour
BE0503 -
BE0504 - Follow up ref SDS 75 4N5M, ref SDS 73 4N5M.
BE0506 -  ..
BE0507 - Cetuximab started.
BE0508 -
BE0509 -           Verify chemotherapy order for 070208.
BE0511 -  ..
BE0512 - Chemotherapy order calls for cetuximab to start 30 - 60 minutes after
BE0513 - Beyadryl pre-tretment. ref SDS 73 IJ41
BE0515 -  ..
BE0516 - Millie received a full dose of cetuximab treatment, even though blood
BE0517 - counts from the test last week on 070503 were below the level for safe
BE0518 - treatment, discussed above, ref SDS 0 MZ3N, and prior review on
BE0519 - 070503, ref SDS 75 P560, citing the record showing Millie has often
BE0520 - has treatments with low blood counts. ref SDS 75 V75F
BE0522 -  ..
BE0523 - Chemotherapy Orders...
BE0524 -
BE0530 -    Auth#                                     Stor BCC LOC
BE0531 -    Visit:  12575738             DOS 20070201
BE0533 -     ..
BE0534 -    Date:  20070201
BE0536 -     ..
BE0537 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
BE0538 -    in combination with Carboplatin in ER-negative, PR-negative,
BE0539 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers
BE0541 -     ..
BE0542 -    Dates to be given:  070201
BE0543 -    Arm 1:Cetuximab alone
BE0545 -     ..
BE0546 -    Diagnosis:  breast cancer
BE0548 -     ..
BE0549 -    ICD-9 codes: 174.9
BE0550 -    Allergies  NKDA
BE0552 -     ..
BE0553 -    Pre-medications 30 - 60 minutes prior to cetuximab infusion
BE0555 -     ..
BE0556 -    4. Diphenhydramine 25 mg IV or  [illegible writing]
BE0557 -
BE0558 -       Benadryl........... ref SDS 58 DC7J
BE0559 -
BE0560 -       On 070329 Brigid changed the Chemotherapy Order reducing
BE0561 -       Diphenhydramine (Benadryl) from 50 mg to 25 mg in order to
BE0562 -       reduce side effects of "restless legs." ref SDS 63 IJ44
BE0564 -        ..
BE0565 -       This was effective, reported above. ref SDS 63 7R6H
BE0567 -     ..
BE0568 -    5. Dexamethasone (??) 10 mg IB or 20 mg IV [handwritten ???]
BE0569 -
BE0570 -       Further premed TBD [barely legible handwriting??]
BE0572 -     ..
BE0573 -    Medication:  (plan to give weekly ********STUDY SUPPLY**********
BE0575 -     ..
BE0576 -    6. Cetuximab (Erbitux) (loading dose)
BE0577 -
BE0578 -              400 mg/m [squared] = 684 mg IV over 120 minutes for
BE0579 -              first dose x 1
BE0580 -
BE0581 -       dose on dcte 20070201   Maximum infusion rate is 5 ml/minute
BE0582 -       (concentration 2 mg/ml)
BE0584 -     ..
BE0585 -    7. Cetuximab (Erbitux) (maintenance dose)
BE0586 -
BE0587 -              250 mg/m [squared] = 428 mg IV (or ____ mg/m[squared] =
BE0588 -              ____mg) IV over 60 or ____ minutes.
BE0589 -
BE0590 -       Maximum infusion rate is 5 ml/minute (concentration 2 mg/ml)
BE0591 -       Infuse once weekly for 8 weeks.  First dose to be given on date
BE0592 -       20070201.
BE0594 -        ..
BE0595 -       Cetuximab is administered undiluted through a low protien
BE0596 -       binding 0.22 micro in-line filter.  Use NS solution to flush the
BE0597 -       line at the end of the infusion.
BE0599 -        ..
BE0600 -       ARM 2:  Administer carboplatin of vital signs are unremarkable
BE0601 -       one hour after cetuximab infusion.
BE0603 -        ..
BE0604 -       Vital signs at baseline, upon cetuximab completion and one hour
BE0605 -       after cetuximab.
BE0606 -
BE0607 -       ****please note start and stop times****
BE0609 -        ..
BE0610 -       Laboratory work:
BE0611 -
BE0612 -          See carboplatin orders
BE0614 -        ..
BE0615 -       x  Notify MD for dose modifications if patient has severe
BE0616 -          acne in form rash
BE0617 -
BE0618 -          CBC with differential and platletes every 4 weeks
BE0619 -          Creatinine and magnesium every 4 weeks
BE0620 -          BUN AST Alk phos Alt Total bilrubin, electrolyes every 8
BE0621 -          weeks.  If levels are outside of normal laboratory values
BE0622 -          notify Brigid NP  (MD/RN) at 415 443 4730
BE0624 -        ..
BE0625 -       x  Physician has discussed risks/benefits of therapy with the
BE0626 -          patient.  Signed consent obtained.
BE0627 -
BE0628 -
BE0629 -          Yes   5.  O2 by nasal cannula at 2 liters/min prn for chest
BE0630 -          pain or SOB
BE0632 -           ..
BE0633 -          Yes   6.  Diphenhydramine 50 mg IV prn x1 for urticaria
BE0634 -          [barely legible], pruritis SOB
BE0636 -           ..
BE0637 -          Yes   7.  Hydrocortizone 100 mg IV prn x1 for urticaria
BE0638 -          [barely legible], pruritis SOB
BE0640 -           ..
BE0641 -          Yes   8.  Albuterol inhaler 2-4 puffs prn SOB or chest
BE0642 -          tightness
BE0644 -           ..
BE0645 -          Yes   9.  Epinephrine 1x1000 (1 mg/ml) 0.3 mg IV prn
BE0646 -          anaphylaxis
BE0648 -           ..
BE0649 -          Breast CC05752 Cetuximab doc 20061024
BE0650 -          Approved 20060615
BE0652 -           ..
BE0653 -          Physician signature [Hope Rugo]
BE0655 -           ..
BE0656 -          Provider#  35313
BE0658 -           ..
BE0659 -          Date:  20010131
BE0660 -
BE0662 -  ..
BE07 -
BE08 -
BE09 - 1045
BE10 -
BE1001 - Cetuximab treatment completed.
BE1002 -
BE1003 - Millie had a 1 hour rest and observation period, required by the
BE1004 - protocol. ref SDS 0 G679
BE1005 -
BE1006 -
BE1007 -
BE1009 -  ..
BE11 -
BE12 -
BE13 - 1145
BE14 -
BE1401 - Nurse disconnected the IV tubes.
BE1403 -  ..
BE1404 - She inserted Herceptin to flush the port.
BE1406 -  ..
BE1407 - She then removed the needle from the port, and swabbed the needle
BE1408 - wound, and placed a temporary bandage.
BE1409 -
BE1410 -
BE1411 -
BE1412 -
BE1413 -
BE15 -

SUBJECTS
Vitals Blood Pressure Pulse Temperature Sa02 Weight Infusion Treatme

BL03 -
BL04 - 0900
BL0501 -  ..
BL0502 - Vitals Show Patient Stable
BL0503 -
BL0504 - Follow up ref SDS 75 AW4L, ref SDS 73 AW4L.
BL0505 -
BL0506 -                    Blood
BL0507 -    Date   Time     Pressure   Pulse  Temprtr  Weight   So2
BL0508 -    .
BL0509 -    070510 1145..... 145  86     54     35.9c           100
BL0510 -    070510 1045..... 149  82     69     37.0c            97
BL0511 -    070510 0900..... 132  75     62     36.8c            99
BL0512 -    070503 1150..... 113  67     59     36.8c            98
BL0513 -    070503 1055..... 125  72     54     36.1c           100
BL0514 -    070503 0915..... 127  70     60     36.9c            99
BL0515 -    070426 1130..... 119  70     57     36.3c            96
BL0516 -    070426 1030..... 141  73     67     36.4c            99
BL0517 -    070426 0900..... 130  78     52     36.5c            97
BL0518 -    070419 1230..... 133  79     57     36.3c            98
BL0519 -    070419 1130..... 141  78     56     37.6c **1        99
BL0520 -    070419 0930..... 153  80     53     36.1c           100
BL0521 -    070412 1120..... 114  65     53     36.6c            96
BL0522 -    070412 1020..... 130  66     57     36.8c            99
BL0523 -    070412 0900..... 116  69     65     36.8c            97
BL0524 -    070405 1130..... 133  75     55     36.2c            97
BL0525 -
BL0526 -            Consistently low pulse, does it reflect low blood pressure
BL0527 -            side effect of cetuximab, or improved fitness from working
BL0528 -            out that benefits emotional stress and immune system?
BL0530 -     ..
BL0531 -    070405 1030..... 114  69     57     36.4c            99
BL0532 -    070405 0900..... 128  78     54     36.5c           100
BL0533 -    070329 1140..... 125  74     53     36.8c            98
BL0534 -    070329 1045..... 125  72     53         c           100
BL0535 -    070329 0900..... 141  76     60     36.6c            99
BL0536 -    070322 1055..... 118  71     55     37.0c            97
BL0537 -    070322 1015..... 120  69     57     37.1c            98
BL0538 -    070322 0900..... 130  70     56     36.0c            98
BL0539 -    070315 1300..... 119  75     58     36.2c            98
BL0540 -    070315 1150..... 137  73     52     36.5c            99
BL0541 -    070315 0945..... 143  85     60     36.4c            97
BL0542 -    070308 1100..... 144  87     70     36.0c            98
BL0543 -    070301 1645..... 125  62     90 *   36.4c
BL0544 -    070301 1505..... 112  69     86 *   36.6c            98
BL0545 -    070222 1145..... 115  73     58     36.3c   147      98
BL0546 -    070222 1045..... 100  60     56     36.6c   147      98
BL0547 -    070222 0930..... 117  63     68     36.2c   147      97
BL0548 -    070215 1200..... 106  66     61     37.0c   147      97
BL0549 -    070215 1055.....  96  61     64     37.0c   147      94
BL0550 -    070215 0930..... 100  64     66     36.7c   147      98
BL0551 -    070208 0920..... 143  70     59     36.5c   147      98
BL0552 -    070201 1330..... 136  74     66             148      94
BL0553 -    070201 1220..... 110  65     62     36.3c   148      96
BL0554 -    070201 1000..... 132  80     65     36.9c   148      99
BL0555 -    061201 1534..... 123  76     76     97.5    150
BL0556 -    061110 1534..... 136  83     73     97.0    150      98
BL0557 -    061020 1534..... 140  79     67     99.8    151      97
BL0558 -    060929 1452..... 141  78     66     98.3    149
BL0559 -    060908 1335..... 139  79     73     98.1    149
BL0560 -    060814 1610..... 139  80     59     98.2    151
BL0561 -    060722 1440..... 142  74     67     98.1    149
BL0562 -    060711.......... 172  87     54     97.5    147
BL0563 -    060623.......... 141  87     71     98.0    147
BL0564 -    060428.......... 129  73     80     99.4    149
BL0565 -    060217.......... 153  81     61     98.6    150
BL0566 -    050916.......... 120  80     80     98.5
BL0567 -
BL0568 -  *    Need vitals taken twice to verify atypical diagnostics.
BL0569 -  **1  Nurses Notes seem to show 97.6 which is cellcius scale.
BL0570 -
BL0571 -
BL0572 -
BL06 -

SUBJECTS
Energy Normal Stable Alert Drive Home After Treatment Tired Sleep 2

BZ03 -
BZ04 - 1130
BZ0501 -  ..
BZ0502 - Energy Normal Stable After Treatment Cetuximab Support Drugs
BZ0503 -
BZ0504 - Follow up ref SDS 75 F54N, ref SDS 73 F54N.
BZ0506 -  ..
BZ0507 - On 060724 diary side effects for cetuximab chemotherapy treatment on
BZ0508 - clinical study drug trial. ref SDS 19 YP4I
BZ0510 -  ..
BZ0511 - Millie was alert after treatment again today, and not wobbly nor
BZ0512 - disoriented.  She was able to drive home without side effects of
BZ0513 - treatment.
BZ0515 -  ..
BZ0516 - Today, we experimented again and drove South on highway 17 toward San
BZ0517 - Jose.  We were able to turn around before getting to Hegenberger road,
BZ0518 - and go North back to Oakland and then taking Highway 24 to Concord,
BZ0519 - because the bridge from the San Francisco - Oakland Bay bridge to get
BZ0520 - to Highway 24 on the way to Walnut Creek was exploded by a truck
BZ0521 - accident a few days ago.  This made the trip home about 50 minutes
BZ0522 - instead of 40 minutes.
BZ0524 -  ..
BZ0525 - After arriving home about 1300, Millie took a nap from about 1410
BZ0526 - until about 1600.  Could relate to side effects from cetuximab
BZ0527 - treatments that cause fatigue, reported on 070116. ref SDS 35 O64M
BZ0528 -
BZ0529 -
BZ0530 -
BZ0531 -
BZ0532 -
BZ0533 -
BZ0534 -
BZ06 -