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: February 8, 2007 07:45 AM Thursday; Rod Welch

Millie at UCSF 1st cycle 2nd treatment Cetuximab for IBC relapse.

1...Summary/Objective
2...Clinic Examination Orientation Starting Treatment Cetuximab
3...Breast Examination Assess Effectiveness Cetuximab Clinical Study
4...Measureable Disease Photographs IBC Rash Improving
5...IBC Rash Improved Measurable Disease Photographs Tape Measure
6...Side Effects Medicated After Weekly Examinations
7...Blood Tests 1 Per Month on Cetuximab Performed at UCSF Saves Time Cost
8...INR 1.8 Low Pulmonary Embolism Needs Increase Coumadin Treatment
9...Pulmonary Embolism Treatment Coumadin Needs Increase Low INR 1.8
10...Infusion Clinic for Cetuximab Treatent
..........Taxotere Capecitabine
..........Cetuxiab Clinical Study
11...Nurses Notes...
12...Side Effects Consultation Pharmacist Heavy Chest Difficult Breathing
13...Schedule Weekly Treatments Continue on Thursdays
14...Blood Counts Good Dose Cetuximab Normal
....Anticoagulattion Therapy INR Low 1.6 PT Patient High 16.3
15...ANC 1760 Well Above 1500 Criteria for Blood Counts Approve Treatment
16...CA 15-3 56 Fall from 68 Cancer Marker Test Pending
17...Preparation for Treatment Required One (1) Attempt to Connect Port
18...Blood Draws 7 Vials for Clinical Study Research
19...Benedryl Reduce Side Effects Cetuximab Chemotherapy Treatment
20...Cetuximab Full Dose Blood Counts on Targets Treatment 1 Hour
21...Vitals Show Patient Stable
22...Energy Normal Stable After Treatment Taxotere Support Drugs

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

1...How will Kaiser be notified of blood test results, which normally
2...Verify chemotherapy order for 070208.

CONTACTS 

SUBJECTS
Examination Treatment Cetuximab 2nd Treatment 1st Cycle Chemotherapy

0603 -
0603 -    ..
0604 - Summary/Objective
0605 -
060501 - Follow up ref SDS C2 0000. ref SDS B2 0000.
060502 -
060503 - Treatment was faster today, because it was given over 1 hour instead
060504 - of 2 hours.  Catherine's work was again excellent.  Brigid seemed to
060505 - see further subsidence of IBC rash intensity.  Patient has increased
060506 - energy since ending chemotherapy treatment with Taxotere and
060507 - capecitabine on 061201. ref SDS 0 PR5L  Millie requested prescription
060508 - for acne-like rash side effects of cetuximab.  Catherine noticed mild
060509 - rash in nurses notes. ref SDS 0 QU8K  UCSF deferred treatment for 2
060510 - weeks until Doctor Rugo makes an examination on 070301 to determine
060511 - severity of the rash. ref SDS 0 FO66
060512 -
060513 -
060514 -
060515 -
060516 -
060517 -
060518 -
060519 -
060521 -  ..
0606 -
0607 -
0608 - Progress
0609 -
060901 - Clinic Examination Orientation Starting Treatment Cetuximab
060902 -
060903 - Follow up ref SDS C2 407N, ref SDS B2 407N.
060904 -
060905 - Agenda...
060906 -
060907 -    1.  Side effects.............................. ref SDS 0 QU8K
060908 -    2.  Breast examination........................ ref SDS 0 FO6H
060909 -    3.  CT test notify Kaiser..................... ref SDS 0 PR5L
060910 -    4.  Measurable disease........................ ref SDS 0 6T6M
060911 -    5.  Blood tests............................... ref SDS 0 XR40
060912 -    6.  Infusion Clinic........................... ref SDS 0 1M6H
060913 -    7.  Blood draws 10 vials...................... ref SDS 0 O56V
060914 -
060915 -
060916 -
0610 -

SUBJECTS
Breast Examination Shows Improvement IBC Rash Left Right Breast Stom

0903 -
090401 -  ..
090402 - Breast Examination Assess Effectiveness Cetuximab Clinical Study
090403 -
090404 - Follow up ref SDS C2 FO6H, ref SDS C0 025H.
090405 -
090406 - Patient history listed in the record on 060722. ref SDS 91 XQ7H
090408 -  ..
090409 - Chronology working with UCSF 1st examination begins on 070130.
090410 - ref SDS 91 S466
090412 -  ..
090413 - Jackie received Millie's letter on 070204 notifying UCSF of the
090414 - meeting at Kaiser on 070202 which resulted in planning for the next CT
090415 - test to evaluate Millie's response to treatment in the clinical study
090416 - at UCSF, to, also, check for pulmonary embolism, and that this test
090417 - requires 1 month notice on when UCSF needs the test for the drug
090418 - trial. ref SDS C4 JJ7O  Brigid advised that UCSF will give Kaiser
090419 - ample notice on when to schedule the next CT test for the study.
090421 -         ..
090422 -        [On 070301 Jackie discussed Kaiser requirements for 1 month
090423 -        notice to order a CT test to evaluate patient progress on the
090424 -        clinical study, and that this would allow time to specify that
090425 -        the test also evaluate pulmonary embolism, ref SDS C9 5Z6L; the
090426 -        doctor advised the next test for the study will be needed to
090427 -        start the 3rd cycle of treatment on 070329; Brigid prepared a
090428 -        radiology request to get the CT test before 070328, and asked
090429 -        the patient to coordinate communications with Kaiser rather
090430 -        than rely on medical professionals. ref SDS C9 UR9J
090432 -         ..
090433 -        [On 070302 Millie submitted a letter to Kaiser presenting
090434 -        results of the meeting today, and conveying UCSF request for CT
090435 -        test before 070328, and specifying testing for pulmonary
090436 -        embolism. ref SDS C0 EZ6T
090438 -         ..
090439 -        [On 070306 follow up letter to Kaiser reminding to order CT
090440 -        test in time for starting next cycle on 070329, and to order
090441 -        test for pulmonary embolism. ref SDS D2 HS3X
090443 -  ..
090444 - General impression is that IBC rash on the left and right breast seems
090445 - stable and possibly less intense after the 1st week of treatment,
090446 - which was a "loading dose" that was double the amount of continuing
090447 - treatments.
090449 -  ..
090450 - Brigid explained the next examination will be done by Doctor Rugo on
090451 - 070301 under the clinical trial protocol for examination to start a
090452 - new cycle of treatment.
090453 -
090454 -
090455 -
090456 -
090457 -
090458 -
0905 -

SUBJECTS
Measureable Disease IBC Rash Photographs Tape Measure Evaluate Progr

1203 -
120401 -  ..
120402 - Measureable Disease Photographs IBC Rash Improving
120403 - IBC Rash Improved Measurable Disease Photographs Tape Measure
120404 -
120405 - Follow up ref SDS C2 6T6M, ref SDS C0 M652.
120406 -
120407 - Jackie advised that measurable disease will generally be assessed each
120408 - 4 week cycle, confirming understandings from the meeting with Doctor
120409 - Rugo on 070130. ref SDS C0 M661
120411 -  ..
120412 - As a result, no photographs or measurements were taken today.
120413 -
120414 -
120415 -
120416 -
120417 -
120418 -
1205 -

SUBJECTS
Cetuximab Side Effects Mild Face Rash Acne-like Medication Prescript

1503 -
150401 -  ..
150402 - Side Effects Medicated After Weekly Examinations
150403 -
150404 - Follow up ref SDS C2 FO66, ref SDS C0 TQ6L.
150405 -
150406 - Millie asked about getting the treatment prescription for acne-like
150407 - rash that has begun to break out on her face.  During the meeting at
150408 - UCSF on 060130 Doctor Rugo indicated treatment is available for this
150409 - side effect of cetuximab chemotherapy. ref SDS C0 IJ5L
150411 -  ..
150412 - Brigid said the rash is barely noticable.  There will not be an
150413 - examination next week.  Doctor Rugo will make the examination to start
150414 - the next cycle on 070301.  The doctor will determine at that time if
150415 - the rash on Millie's face is severe enough to prescribe treatment.
150416 -
150417 -     [On 070215 Nurse's Notes report cetuximab rash continues, UCSF
150418 -     pharmacy doctor prescribed treatment. ref SDS C6 SK9O
150420 -      ..
150421 -     [On 070222 Brigid wrote prescription for Benza Clin Clindamycin
150422 -     benzoyl peroxide gel medication to treat facial rash side effects
150423 -     from cetuximab chemotherapy treatments. ref SDS C7 FO66
150424 -
150425 -
150426 -
150427 -
1505 -

SUBJECTS
Blood Tests Cetuximab Monthly Clinical Study Drug Trial Performed at

1803 -
180401 -  ..
180402 - Blood Tests 1 Per Month on Cetuximab Performed at UCSF Saves Time Cost
180403 -
180404 - Follow up ref SDS C2 XR40.
180405 -
180406 - No blood test today for cetuximab treatment.
180408 -  ..
180409 - Jackie advised that she has scheduled Millie for the next blood test
180410 - to start the next cycle of treatment with cetuximab on 070301 1145,
180411 - per planning on 070201. ref SDS C2 XR40
180413 -  ..
180414 - Jackie explained that Millie can go to the Chemotherapy Clinic on the
180415 - 5th floor any time on 070301 to get blood drawn; there is no
180416 - requirement for a specific time.
180418 -  ..
180419 - Jackie advised that payment for blood tests at UCSF, discussed on
180420 - 070201, ref SDS C2 G55H, is part of standard of care.
180421 -
180422 -
180424 -  ..
180425 - INR 1.8 Low Pulmonary Embolism Needs Increase Coumadin Treatment
180426 - Pulmonary Embolism Treatment Coumadin Needs Increase Low INR 1.8
180427 -
180428 - Follow up ref SDS C2 6U5J.
180429 -
180430 - After treatment today at UCSF, on the way home Millie stopped at
180431 - Kaiser in Walnut Creek and got a blood test in the 1st floor
180432 - laboratory. ref SDS C5 JR6I  This blood test was ordered by Gloria in
180433 - the Kaiser Coagulation  Control Clinic to evaluate INR diagnostics
180434 - that help manage Coumadin (warfarin) treatments for pulmonary
180435 - embolism.
180437 -         ..
180438 -        [...in another record later today, Gloria reported INR was only
180439 -        1.8 for the test today. ref SDS C5 5L9M
180441 -         ..
180442 -        [On 070215 blood test INR 2.5, so can skip blood test for INR
180443 -        the following week. ref SDS C6 6U5J
180445 -  ..
180446 - Millie wants to manage Coumadin treatments with blood tests that fit
180447 - the cycle of blood tests at UCSF for treatment on the drug trial.
180448 -
180449 -        [...below, Catherine seemed to indicate that the Chemotherpay
180450 -        Clinic prefers that patients get blood tests at previously
180451 -        scheduled times. ref SDS 0 Q659
180453 -  ..
180454 - How will Kaiser be notified of blood test results, which normally
180455 - occurs through Kaiser computers? ref SDS C2 6U5J
180456 -
180457 -        [...in another record today, Millie notifies Kaiser about
180458 -        planning to consolidate blood tests for cancer and for
180459 -        pulmoanry embolism. ref SDS C5 X24X
180460 -
180461 -
180462 -
1805 -

SUBJECTS
Cetuximab 1st Cycle 2nd Treatment Chemotherapy 8th Cycle IBC 3rd Rel

2103 -
2104 - 0850
210501 -  ..
210502 - Infusion Clinic for Cetuximab Treatent
210503 -
210504 - Follow up ref SDS C2 1M6H.
210505 -
210506 - Jackie accomanied Millie into the Infusion Clinic again today.
210508 -  ..
210509 - Millie received 2nd treatment of 1st cycle with Cetuximab, and the 9th
210510 - treatment for 3rd relapse of IBC.
210512 -           ..
210513 -          Taxotere Capecitabine
210514 -
210515 -
210516 -                   Relapse Treatments
210517 -
210518 -      1.  Cycle 09 and 01 ................... 060721, ref SDS 89 407N
210519 -      2.  Cycle 10 and 02 ................... 060814, ref SDS 98 LY6O
210520 -      3.  Cycle 11 and 03 ................... 060908, ref SDS A1 407N
210521 -      4.  Cycle 12 and 04 ................... 060929, ref SDS A3 407N
210522 -      5.  Cycle 13 and 05 ................... 061020, ref SDS A7 407N
210523 -      6.  Cycle 14 and 06 ................... 061110, ref SDS B0 407N
210524 -      7.  Cycle 15 and 07 ................... 061201, ref SDS B2 407N
210526 -           ..
210527 -          Cetuxiab Clinical Study
210528 -
210529 -                   Total    Cetuximab
210530 -      8.  Cycle 01 and 08 and 01............. 070201, ref SDS C2 407N
210531 -      9.  Cycle 01 and 09 and 02............. 070208, ref SDS 0 407N
210533 -  ..
210534 - Nurses Notes...
210535 -
210544 -     ..
210545 -    UCSF Log Time...
210546 -
210547 -          In....... 0845
210548 -          Out...... 1130
210549 -          Visit.... 3.0  Hours
210551 -      ..
210552 -     Pain Assessment...
210553 -
210554 -          x
210555 -          0123456789 10
210556 -
210557 -     <923k
210558 -     Administration Site:  Right Port Catheter
210559 -     Needle Size:          20 G 1"
210560 -     Blood Return Good:    Yes
210562 -      ..
210563 -     Remind patient to call MD if temp > 101 F, Shaking Chills
210564 -
210565 -            This protocol differs from Kaiser requirements, reported on
210566 -            041202. ref SDS 49 IX9N
210568 -  ..
210569 - Jackie brought 10 blood vials for the clinical study research.
210570 -
210574 -  ..
210575 - Millie had a blood draw last week on Wednesday, 070131. ref SDS C1
210576 - P56K
210577 -
210578 -
210579 -
210580 -
2106 -

SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A

3003 -
3004 - 0911
300501 -  ..
300502 - Side Effects Consultation Pharmacist Heavy Chest Difficult Breathing
300503 -
300504 - Follow up ref SDS C2 QU8K, ref SDS B2 QU8K.
300506 -  ..
300507 - Catherine asked Millie about side effects...
300508 -
300509 -            Rash like acne
300510 -
300511 -               Mild condition around the nose, discussed with Brigid,
300512 -               nurse practitioner this morning, per above. ref SDS 0
300513 -               FO66
300514 -
300516 -             ..
300517 -            Tired, fatigued - pulmonary emoblism...
300518 -
300519 -               Questions on fatigue, shortness of breath and other
300520 -               symptoms of pulmonary embolism were referred to the
300521 -               meeting with Doctor Rugo on 070130, ref SDS C0 CV5L, and
300522 -               citing case study listed on 060722. ref SDS 90 ZV41
300524 -                ..
300525 -               On 070204 UCSF notified no initial side effects of
300526 -               treatment, and energy has increased; planning for CT
300527 -               test to evaluate pulmonary embolism. ref SDS C4 JJ7O
300528 -
300530 -             ..
300531 -            Heavy chest - shortness of breathing
300532 -
300533 -               Patient history was reported to UCSF on 070130.
300534 -               ref SDS C0 RT6I
300535 -
300536 -               Condition seems improved, as reported on 070204.
300537 -               ref SDS C4 JJ7O
300539 -             ..
300540 -            Cough - clearing throat
300541 -
300542 -               This condition seems improved, as reported to the doctor
300543 -               on 070130. ref SDS C0 RT6I
300544 -
300546 -             ..
300547 -            Dry hands and feet...
300548 -
300549 -               This condition seems much improved since ending
300550 -               treatment with Taxotere and capecitiabine on 061201.
300551 -
300553 -             ..
300554 -            Eyes tearing
300555 -
300556 -               This seems improved since ending treatment with Taxoter
300557 -               and capecitabine on 061201.
300558 -
300560 -             ..
300561 -            Nausea, vomitting
300562 -
300563 -               Problems with Taxotere and capecitabine reported on
300564 -               061110, ref SDS B0 D19M, did not occur this past week
300565 -               after treatment with cetuximab.  As a result, there was
300566 -               no pre-treatment with Decadron today, per below.
300567 -               ref SDS 0 G57I
300568 -
300570 -             ..
300571 -            Sores in mouth
300572 -
300573 -               None yet, cleaning mouth carefully to avoid problem.
300574 -
300575 -
300576 -
300577 -
3006 -

SUBJECTS
Schedule Treatment Weekly Thursday 0800 4 Week Cycles Clinical Study

3303 -
330401 -  ..
330402 - Schedule Weekly Treatments Continue on Thursdays
330403 -
330404 - Follow up ref SDS C2 QK6L, ref SDS B2 QK6L.
330406 -  ..
330407 - Today, Millie's next treatment is scheduled for 070222 0830.
330409 -  ..
330410 - Blood draw will not be needed for 3 weeks on 070301, per discusison
330411 - with Brigid, reported on 070201. ref SDS C2 XR40
330412 -
330413 -
330414 -
330415 -
3305 -

SUBJECTS
Blood Counts Good Test 070131 Enables Full Dose Treatment Cetuximab

3603 -
360401 -  ..
360402 - Blood Counts Good Dose Cetuximab Normal
360403 -
360404 - Follow up ref SDS C2 Q659, ref SDS B2 Q659.
360406 -  ..
360407 - There was no blood test today.  The next test is scheduled for 070301
360408 - 1130 to start the next cycle.
360410 -  ..
360411 - Catherine seemed to indicate today, that the Chemotherapy Infusion
360412 - clinic on the 5th floor schedules specific times for patients to get
360413 - blood tests, clarifying discussion earlier with Brigid and Jackie in
360414 - the Oncology Clinic on the 2nd floor. ref SDS 0 444L
360415 -
360416 -
360417 -
360418 -
3605 -

SUBJECTS
Anticoagulation Therapy Pulmonary Emboli INR Low 1.8 PT Patient No R

3903 -
390401 -     ..
390402 -    Anticoagulattion Therapy INR Low 1.6 PT Patient High 16.3
390403 -
390404 -    Follow up ref SDS C2 SE6N, ref SDS B2 SE6N.
390405 -
390406 -    PT, patient    H        ??.? sec           8.9    -     11.1
390407 -    PT INR         L         1.8 sec           2      -      3
390409 -  ..
390410 - Millie stopped at Kaiser on the way home after treatment today to get
390411 - a blood test for pulmonary embolism.  In another record, Gloria
390412 - submitted results of the test today, showing INR of 1.8. ref SDS C5
390413 - 5L9M
390414 -
390415 -        [On 070215 blood test INR 2.5, so can skip blood test for INR
390416 -        the following week. ref SDS C6 6U5J
390417 -
390418 -
390419 -
390420 -
3905 -

SUBJECTS
Absolute Neutrophils Count ANC 1760 Well Above 1500 Required for Tre

4203 -
420401 -  ..
420402 - ANC 1760 Well Above 1500 Criteria for Blood Counts Approve Treatment
420403 -
420404 - Follow up ref SDS C2 P560, ref SDS B2 P560.
420405 -
420406 - No blood test for treatment today.
420407 -
420408 -
420409 -
4205 -

SUBJECTS
CA 15-3 67 Rise from 61 Cancer Marker Current Blood Test Reversing P

4503 -
450401 -  ..
450402 - CA 15-3 56 Fall from 68 Cancer Marker Test Pending
450403 -
450404 - Follow up ref SDS C2 2N5J, ref SDS B2 2N5J.
450405 -
450406 - On 070202 CA 15-3 dropped to 52 and rose to 56 in next 2 tests.
450407 - ref SDS C3 087J
450409 -  ..
450410 - CA 15-3 for blood test today on 070208 taken for INR diagnostics to
450411 - evaluate pulmonary embolism, was not available today.
450412 -
450413 -     [On 070215 comment that Arlette mentioned in a telphone call that
450414 -     she recalled CA 15-3 for the blood test on 070208 was 56,
450415 -     indicating stabalinzing conditions. ref SDS C6 ER5O
450417 -      ..
450418 -     [On 070228 letter to UCSF requests coordination Kaiser on results
450419 -     of blood test today for CA 15-3 to evaluate IBC progression, and
450420 -     assess changing treatments. ref SDS C8 ED5H
450421 -
450422 -
450423 -
450424 -
4505 -

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

4903 -
4904 - 0907
490501 -  ..
490502 - Preparation for Treatment Required One (1) Attempt to Connect Port
490503 -
490504 - Follow up ref SDS C2 EB7J, ref SDS B2 EB7J.
490506 -  ..
490507 - Catherine connected the IV tubes to the port....
490509 -       ..
490510 -      Interlink System Vented Paclitaxel set
490512 -  ..
490513 - There were no problems getting blood to flow from the port for the
490514 - blood sample research vials, as occurred previously on 070201.
490515 - ref SDS C2 DC5W
490516 -
490517 -        [On 070222 sluggish blood removal from port again; reported to
490518 -        doctor. ref SDS C7 DC5W
490520 -         ..
490521 -        [On 070301 problem experienced on 070222 did not occur the
490522 -        following week. ref SDS D0 DC5W
490524 -  ..
490525 - Catherine flushed the port with saline.
490526 -
490527 -
490528 -
490529 -
4906 -

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

5303 -
530401 -  ..
530402 - Blood Draws 7 Vials for Clinical Study Research
530403 -
530404 - Follow up ref SDS C2 O56V.
530405 -
530406 - Catherine drew 7 vials of blood for the study.  This supplements 10
530407 - vials drawn to start the clinical study last week on 070201.
530408 - ref SDS C2 O56V
530410 -  ..
530411 - Understanding that going forward, there will only one multi-blood
530412 - draw of 7 vials to start each new cycle.
530414 -  ..
530415 - Sluggish, slow blood removal from the port that occured last week on
530416 - 070201, ref SDS C2 G46H, did not occur today.  Blood flowed normally
530417 - through port catheter.
530418 -
530419 -
530420 -
530421 -
5305 -

SUBJECTS
Benadryl Pre-treatment Prepares Patient for Cetuximab Chemotherapy A

5503 -
5504 - 0850
550501 -  ..
550502 - Benedryl Reduce Side Effects Cetuximab Chemotherapy Treatment
550503 -
550504 - Follow up ref SDS C2 DC7J, ref SDS B2 DC7J.
550505 -
550506 - Benadryl (diphenhydramine) started.   50 MG....... ref SDS 0 IJ41
550508 -         ..
550509 -        Purpose reported on 060721. ref SDS 89 DC7J
550511 -  ..
550512 - Chemotherpay order calls for Benadryl (diphenhydramine) pre-treatment
550513 - 30 - 60 minutes prior to cetuximab infusion, shown below. ref SDS 0
550514 - IJ41
550515 -
550516 -
550518 -  ..
5506 -
5507 -
5508 - 0901
5509 -
550901 - Benedryl completed equipment beeps.
550902 -
550903 -
550905 -  ..
5510 -
5511 -
5512 -
5513 -
551301 - Decadron (Dexamethasone) IV treatment started. 20 MG. ref SDS 0 FM4M
551302 -
551303 -        Purpose reported on 060721. ref SDS 89 8G9G
551305 -  ..
551306 - Catherine advised that since Millie reports no side effects of nausea
551307 - and vomitting following treatment with cetuxmiab last week on 070201,
551308 - per above, ref SDS 0 D19M,
551309 -
551311 -  ..
5514 -
5515 -
5516 -
5517 -
551701 - Decadron completed -- not reported.
551702 -
551703 -
5518 -

SUBJECTS
Cetuximab 1st Cycle 2nd Treatment Clinical Study Drug Trial Treatmen

5703 -
5704 - 0915
570501 -  ..
570502 - Cetuximab Full Dose Blood Counts on Targets Treatment 1 Hour
570503 -
570504 - Follow up ref SDS C2 4N5M, ref SDS B2 4N5M.
570505 -
570506 - Cetuximab started.
570507 -
570508 -           Verify chemotherapy order for 070208.
570510 -  ..
570511 - Chemotherapy Orders...
570512 -
570518 -    Auth#                                     Stor BCC LOC
570519 -    Visit:  12575738             DOS 20070201
570521 -     ..
570522 -    Date:  20070201
570524 -     ..
570525 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
570526 -    in combination with Carboplatin in ER-negative, PR-negative,
570527 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers
570529 -     ..
570530 -    Dates to be given:  070201
570531 -    Arm 1:Cetuximab alone
570533 -     ..
570534 -    Diagnosis:  breast cancer
570536 -     ..
570537 -    ICD-9 codes: 174.9
570538 -    Allergies  NKDA
570540 -     ..
570541 -    Pre-medications 30 - 60 minutes prior to cetuximab infusion
570543 -     ..
570544 -    8. Diphenhydramine 50 mg IV or  [illegible writing]
570546 -     ..
570547 -    9. Dexamethasone (??) 10 mg IB or 20 mg IV [handwritten ???]
570548 -
570549 -       Further premed TBD [barely legible handwriting??]
570551 -     ..
570552 -    Medication:  (plan to give weekly ********STUDY SUPPLY**********
570554 -     ..
570555 -   10. Cetuximab (Erbitux) (loading dose)
570556 -
570557 -              400 mg/m [squared] = 684 mg IV over 120 minutes for
570558 -              first dose x 1
570559 -
570560 -       dose on dcte 20070201   Maximum infusion rate is 5 ml/minute
570561 -       (concentration 2 mg/ml)
570563 -     ..
570564 -   11. Cetuximab (Erbitux) (maintenance dose)
570565 -
570566 -              250 mg/m [squared] = 428 mg IV (or ____ mg/m[squared] =
570567 -              ____mg) IV over 60 or ____ minutes.
570568 -
570569 -       Maximum infusion rate is 5 ml/minute (concentration 2 mg/ml)
570570 -       Infuse once weekly for 8 weeks.  First dose to be given on date
570571 -       20070201.
570573 -        ..
570574 -       Cetuximab is administered undiluted through a low protien
570575 -       binding 0.22 micro in-line filter.  Use NS solution to flush the
570576 -       line at the end of the infusion.
570578 -        ..
570579 -       ARM 2:  Administer carboplatin of vital sighs are unremarkable
570580 -       one hour after cetuximab infusion.
570582 -        ..
570583 -       Vital signs at baseline, upon cetuximab completion and one hour
570584 -       after cetuximab.
570585 -
570586 -       ****please note start and stop times****
570588 -        ..
570589 -       Laboratory work:
570590 -
570591 -          See carboplatin orders
570593 -        ..
570594 -       x  Notify MD for dose modifications if patient has severe
570595 -          acneinform rash
570596 -
570597 -          CBC with differential and platletes every 4 weeks
570598 -          Creatinine and magnesium every 4 weeks
570599 -          BUN AST Alk phos Alt Total bilrubin, electrolyes every 8
570600 -          weeks.  If levels are outside of normal laboratory values
570601 -          notify Brigid NP  (MD/RN) at 415 443 4730
570603 -        ..
570604 -       x  Physician has discussed risks/benefits of therapy with the
570605 -          patient.  Signed consent obtained.
570606 -
570607 -
570608 -          Yes  No   O2 by nasal cannula at 2 liters/min prn for chest
570609 -          pain or SOB
570611 -           ..
570612 -          Yes  No   Diphenhydramine 50 mg IV prn x1 for urticaria
570613 -          [barely legible], pruritis SOB
570615 -           ..
570616 -          Yes  No   Hydrocortizone 100 mg IV prn x1 for urticaria
570617 -          [barely legible], pruritis SOB
570619 -           ..
570620 -          Yes  No   Albuterol inhaler 2-4 puffs prn SOB or chest
570621 -          tightness
570623 -           ..
570624 -          Yes  No   Epinephrine 1x1000 (1 mg/ml) 0.3 mg IV prn
570625 -          anaphylaxis
570627 -           ..
570628 -          Breast CC05752 Cetuximab doc 20061024
570629 -          Approved 20060615
570631 -           ..
570632 -          Physician signature [Hope Rugo]
570634 -           ..
570635 -          Provider#  35313
570637 -           ..
570638 -          Date:  20010131
570639 -
570641 -  ..
5707 -
5708 -
5709 - 1015
5710 -
571001 - Cetuximab treatment completed.
571002 -
571003 - Millie had a 1 hour rest and observation period.
571004 -
571005 -
571007 -  ..
5711 -
5712 -
5713 - 1115
5714 -
571401 - Catherine disconnected the IV tubes.
571403 -  ..
571404 - She inserted Herceptin to flush the port.
571406 -  ..
571407 - She then removed the needle from the port, and swabbed the needle
571408 - wound, and placed a temporary bandage.
571409 -
571410 -
571411 -
571412 -
571413 -
5715 -

SUBJECTS
Vitals Blood Pressure Pulse Temperature Sa02 Weight Infusion Treatme

6003 -
6004 - 0920
600501 -  ..
600502 - Vitals Show Patient Stable
600503 -
600504 - Follow up ref SDS C2 AW4L, ref SDS B2 AW4L.
600505 -
600506 - Catherine took vitals after starting Taxotere drip treatment...
600507 -
600508 -                    Blood
600509 -    Date   Time     Pressure   Pulse  Temprtr  Weight   So2
600511 -     ..
600512 -    070208 0920..... 143  70     59     36.5c   147      98
600513 -    070201 1330..... 136  74     66             148      94
600514 -    070201 1220..... 110  65     62     36.3c   148      96
600515 -    070201 1000..... 132  80     65     36.9c   148      99
600516 -    061201 1534..... 123  76     76     97.5    150
600517 -    061110 1534..... 136  83     73     97.0    150      98
600518 -    061020 1534..... 140  79     67     99.8    151      97
600519 -    060929 1452..... 141  78     66     98.3    149
600520 -    060908 1335..... 139  79     73     98.1    149
600521 -    060814 1610..... 139  80     59     98.2    151
600522 -    060722 1440..... 142  74     67     98.1    149
600523 -    060711.......... 172  87     54     97.5    147
600524 -    060623.......... 141  87     71     98.0    147
600525 -    060428.......... 129  73     80     99.4    149
600526 -    060217.......... 153  81     61     98.6    150
600527 -    050916.......... 120  80     80     98.5
600528 -
600529 -  *  Need vitals taken today, maybe twice.
600530 -
600531 -
600532 -
600533 -
6006 -

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

6303 -
6304 - 1705
630501 -  ..
630502 - Energy Normal Stable After Treatment Taxotere Support Drugs
630503 -
630504 - Follow up ref SDS C2 F54N, ref SDS B2 F54N.
630506 -  ..
630507 - On 060724 diary side effects for cetuximab chemotherapy treatment on
630508 - clinical study drug trial. ref SDS 92 YP4I
630510 -  ..
630511 - On 070204 Millie reported to Kaiser and to UCSF increased energy,
630512 - working out in the gym. ref SDS C4 HF5H
630514 -  ..
630515 - Millie was alert after treatment again today, and not wobbly nor
630516 - disoriented.
630517 -
630518 -
630519 -
630520 -
630521 -
630522 -
630523 -
6306 -