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 8, 2007 10:30 AM Thursday;
Rod Welch
Millie at UCSF 2nd cycle 2nd treatment Cetuximab for IBC relapse.
1...Summary/Objective
2...Clinic Examination Orientation Starting Treatment Cetuximab
3...Treatment Continued CA 15-3 Big Improvement Meeting Cancelled
4...CA 15-3 Improvement Aligns with Subsiding IBC Meeting Cancelled
5...Meeting Cancelled on Changing Treatment Dramatic Improvement CA 15-3
6...Measureable Disease Photographs IBC Rash Improving
7...IBC Rash Improved Measurable Disease Photographs Tape Measure
8...Side Effects Medicated After Weekly Examinations
9...Blood Tests 1 Per Month on Cetuximab Performed at UCSF Saves Time Cost
10...INR 2.5 Low Pulmonary Embolism Needs Increase Coumadin Treatment
11...Pulmonary Embolism Treatment Coumadin Needs Increase Low INR 2.5
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 2.5 Normal Stable 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...Benedryl 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
..............
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CONTACTS
SUBJECTS
Examination Treatment Cetuximab 2nd Treatment 2nd Cycle Chemotherapy
0603 -
0603 - ..
0604 - Summary/Objective
0605 -
060501 - Follow up ref SDS E1 0000. ref SDS D8 0000.
060502 -
060503 - Millie received the 2nd treatment of the 2nd cycle, and 6th overall
060504 - treatment for IBC with cetuximab on clinical study. Good news today
060505 - that ANC blood counts from testing this morning increased above the
060506 - 1500 level, signaling safety for getting chemotherapy treatments, and
060507 - reversing the declining trend that began last July. ref SDS 0 P560
060508 - Since CA 15-3 has also improved by falling the lowest level in over a
060509 - year, ref SDS 0 2N5J, the doctor cancelled a meeting scheduled this
060510 - morning to consider changing treatments. ref SDS 0 PN6M
060511 -
060512 -
060513 -
060514 -
060516 - ..
0606 -
0607 -
0608 - Progress
0609 -
060901 - Clinic Examination Orientation Starting Treatment Cetuximab
060902 -
060903 - Follow up ref SDS E1 407N, ref SDS D8 407N.
060904 -
060905 - Normally there is no meeting on the 2nd treatment of a cycle in the
060906 - cetuximab drug trial, however, last week the doctor planned a meeting
060907 - today for follow up examination; this morning the meeting was
060908 - cancelled, per below, ref SDS 0 FO6H, leaving the normal agenda for
060909 - the 2nd treatment in a cycle...
060911 - ..
060912 - Agenda...
060913 -
060914 - 1. Infusion Clinic........................... ref SDS 0 1M6H
060915 - 2. Side effects.............................. ref SDS 0 QU8K
060916 -
060917 -
060918 -
060919 -
060920 -
0610 -
SUBJECTS
Breast Examination Meeting Cancelled ANC CA 15-3 Blood Test Diagnost
1103 -
110401 - ..
110402 - Treatment Continued CA 15-3 Big Improvement Meeting Cancelled
110403 - CA 15-3 Improvement Aligns with Subsiding IBC Meeting Cancelled
110404 - Meeting Cancelled on Changing Treatment Dramatic Improvement CA 15-3
110405 -
110406 - Follow up ref SDS E1 FO6H, ref SDS D8 FO6H.
110407 -
110408 - The receptionist advised that a few minutes earlier Jackie came by and
110409 - told her that Doctor Rugo has cancelled the meeting this morning to
110410 - assess changing the treatment.
110411 -
110412 - [On 070315 Millie asked about coping emotionally with major
110413 - changes in assessment of treatment on the cetuximab clinical
110414 - study. ref SDS E4 6A7J
110416 - ..
110417 - On 070301 Doctor Rugo scheduled an interim meeting today because blood
110418 - tests for ANC showed a weakening immune system, and CA 15-3 cancer
110419 - marker was questionable, ref SDS E0 Q57O, along with IBC metastatic
110420 - disease expanding. ref SDS E0 LB5L The record at that time was not
110421 - clear whether progression of disease occurred mostly before or after
110422 - 070201 when Millie started treatment on the clinical study with
110423 - cetuximab. Expanding IBC during the drug trial seems conflicting with
110424 - clinical examinations showing intensity of disease has subsided since
110425 - 070201. ref SDS E0 M68J
110427 - ..
110428 - Previously, on 070130 the doctor planned to add carboplatin that
110429 - increases the strength of treatment, when IBC progresses. ref SDS C4
110430 - N13L There was, however, concern last week on 070301 that adding
110431 - carboplatin would further decrease ANC blood counts, which were
110432 - already below the level of safety for approving treatment. Weekly
110433 - treatments may not provide enough time for Millie's blood counts to
110434 - recover sufficiently to avoid the risk of infectious diseases with a
110435 - weakening immune system. ref SDS E0 VF60
110437 - ..
110438 - The doctor ordered another blood test today out of sequence for the
110439 - treatment protocol of monthly tests, but for the purpose of evaluating
110440 - ANC, cited during the meeting at UCSF on 070201. ref SDS E0 528F If
110441 - ANC has increased in the test today, then treatment can proceed, and
110442 - if CA 15-3 has also increased, then treatment may be changed by adding
110443 - carboplatin. If ANC falls, treatment may have to be delayed, the
110444 - dosage reduced, or other measures taken to increase ANC, e.g.,
110445 - nupogeon. If CA 15-3 has fallen, then treatment can continue today
110446 - unchanged. ref SDS E0 QN3F
110448 - ..
110449 - Yesterday, Kaiser submitted data for CA 15-3 tests in February,
110450 - ref SDS E3 9Z9N, and results of the test last week on 070301 at UCSF
110451 - were also submitted; all test results are very favorable. ref SDS E3
110452 - U85L Additionally, ANC for the blood test this morning was favorable,
110453 - reversing a 6 month trend of decline, and rising above the level
110454 - prescribed for safe treatment. ref SDS 0 P560
110456 - ..
110457 - The doctor evidently cancelled the meeting this morning, because
110458 - testing now seems to validate impressions of clinical improvement,
110459 - indicating the current treatment with cetuximab alone is effective for
110460 - Millie, and so there is no reason to change the protocol at this time
110461 - by adding carboplatin.
110462 -
110463 - [On 071023 UCSF explains cancer marker applied to look more
110464 - carefully and does not signal consideration of treatment change
110465 - based on a cut off diagnostic of 80 (using Kaiser Lab
110466 - calibration methods). ref SDS E8 V63L
110467 -
110468 -
110469 -
1105 -
SUBJECTS
Measureable Disease IBC Rash Photographs Tape Measure Evaluate Progr
1403 -
140401 - ..
140402 - Measureable Disease Photographs IBC Rash Improving
140403 - IBC Rash Improved Measurable Disease Photographs Tape Measure
140404 -
140405 - Follow up ref SDS E1 6T6M, ref SDS D8 6T6M.
140406 -
140407 -
140408 -
140409 -
1405 -
SUBJECTS
Cetuximab Side Effects Mild Face Rash Acne-like Medication Prescript
2003 -
200401 - ..
200402 - Side Effects Medicated After Weekly Examinations
200403 -
200404 - Follow up ref SDS E1 FO66, ref SDS D8 FO66.
200405 -
200406 -
200407 -
200408 -
2005 -
SUBJECTS
Blood Tests Cetuximab Monthly Clinical Study Drug Trial Performed at
2303 -
230401 - ..
230402 - Blood Tests 1 Per Month on Cetuximab Performed at UCSF Saves Time Cost
230403 -
230404 - Follow up ref SDS E1 XR40, ref SDS D8 XR40.
230405 -
230406 - Blood test today, results reported below. ref SDS E1 Q659
230407 -
230409 - ..
230410 - INR 2.5 Low Pulmonary Embolism Needs Increase Coumadin Treatment
230411 - Pulmonary Embolism Treatment Coumadin Needs Increase Low INR 2.5
230412 -
230413 - Follow up ref SDS E1 6U5J, ref SDS D8 6U5J.
230414 -
230415 - INR was not tested today, per below. ref SDS 0 SE6N
230416 -
230417 -
230418 -
230419 -
230420 -
2305 -
SUBJECTS
Cetuximab 2nd Cycle 2nd Treatment 6th Total Treatment Chemotherapy 9
2603 -
2604 - 0830
260501 - ..
260502 - Infusion Clinic for Cetuximab Treatent
260503 -
260504 - Follow up ref SDS E1 1M6H, ref SDS D8 1M6H.
260505 -
260506 - Millie checked in at the Infusion Clinic to get the blood test planned
260507 - last week on 070301, ref SDS E0 N15K, and per above. ref SDS 0 CJ3I
260509 - ..
260510 - The receptionist, Nola, said that Millie is not scheduled for a blood
260511 - test today, per below. ref SDS 0 JG4G
260512 -
260513 - [On 070315 similar mistake, UCSF had no record of Millie being
260514 - scheduled for treatment. ref SDS E4 1M6H
260515 -
260516 - [On 070329 coordination scheduling next blood test successful.
260517 - ref SDS E7 Q659
260519 - ..
260520 - [On 070329 coordination continuing challenge on clinical study.
260521 - ref SDS E6 RM4G
260523 - ..
260524 - Millie explained patient history getting weekly treatments with
260525 - cetuximab on clinical study; and, that her doctor ordered a blood test
260526 - today to verify ANC has not dropped too low for treatment. ref SDS E0
260527 - Q57O Millie asked to see Catherine, who is familiar with her protocol
260528 - and blood test issues.
260530 - ..
260531 - Nola said that Catherine is not in the clinic today. She checked the
260532 - computer and found Millie has been getting weekly treatments since
260533 - 070201 on the cetuximab clinical study. She also found Millie's ANC
260534 - was low last week on 070301. ref SDS E1 P560 Nola took immediate
260535 - action and scheduled the blood test to evaluate ANC and a nurse was
260536 - asisgned to draw blood.
260538 - ..
260539 - Catherine is out today. ______________________ was the nurse.
260541 - ..
260542 - Millie said treatment did not go well today. There was no review of
260543 - side effects, per below, ref SDS 0 QU8K, which Catherine has done
260544 - regularly, and obtained guidance from the doctor and pharmacy, when
260545 - needed. Nobody checked on her. They did not know the protocol for
260546 - cetuximab requires a one (1) hour rest period after treatment.
260547 - ref SDS 0 G679 Vitals were taken only once, rather than 3 times as,
260548 - on previous treatments. ref SDS 0 AW4L
260549 -
260550 - [On 070315 issues resolved on subsequent treatment. ref SDS E4
260551 - QG7K
260553 - ..
260554 - Millie was also disturbed by people in adjacent chairs. The room was
260555 - small. A patient getting treatment carried on a continuous, loud
260556 - discussion with several friends crammed into a small space. Millie
260557 - was pleased the patient felt well enough to communicate energetically,
260558 - however, this prevented resting called out in Millie's protocol.
260559 -
260560 - [On 070315 issue improved on next visit. ref SDS E4 QG8I
260561 -
260562 -
260563 -
260564 -
260566 - ..
2606 -
2607 -
2608 - 1033
2609 -
260901 - Millie received 6th overall and 2nd treatment of 2nd cycle with
260902 - Cetuximab, starting from 070201, ref SDS C6 G68I, and the 13th
260903 - treatment for 3rd relapse of IBC, beginning on 060721. ref SDS 89 407N
260905 - ..
260906 - Taxotere Capecitabine
260907 -
260908 - Follow up ref SDS E1 PR8Q, ref SDS D8 PR8Q.
260909 -
260910 - Relapse Treatments
260911 -
260912 - 1. Cycle 09 and 01 ................... 060721, ref SDS 89 407N
260913 - 2. Cycle 10 and 02 ................... 060814, ref SDS 98 LY6O
260914 - 3. Cycle 11 and 03 ................... 060908, ref SDS A1 407N
260915 - 4. Cycle 12 and 04 ................... 060929, ref SDS A3 407N
260916 - 5. Cycle 13 and 05 ................... 061020, ref SDS A8 407N
260917 - 6. Cycle 14 and 06 ................... 061110, ref SDS B2 407N
260918 - 7. Cycle 15 and 07 ................... 061201, ref SDS B4 407N
260920 - ..
260921 - Cetuxiab Clinical Study
260922 -
260923 - Follow up ref SDS E1 7T3H, ref SDS D8 7T3H.
260924 -
260925 - Total Cetuximab
260926 - 8. Cycle 01 and 08 and 01 01.......... 070201, ref SDS C6 SG8I
260927 - 9. Cycle 01 and 08 and 02 02.......... 070208, ref SDS C9 SG8I
260928 - 10. Cycle 01 and 08 and 03 03.......... 070215, ref SDS D2 SG8I
260929 - 11. Cycle 01 and 08 and 04 04.......... 070222, ref SDS D8 SG8I
260930 - 12. Cycle 02 and 09 and 01 05.......... 070301, ref SDS E1 SG8I
260931 - 13. Cycle 02 and 09 and 02 06.......... 070308, ref SDS 0 SG8I
260933 - ..
260934 - Nurses Notes...
260945 - ..
260946 - UCSF Log Time...
260947 -
260948 - Blood
260949 - Test Infusion
260950 -
260951 - In....... 0830 1045
260952 - Out...... 0840 1245
260953 - Visit.... 10 Min 3.0 Hours
260955 - ..
260956 - Pain Assessment...
260957 -
260958 - x
260959 - 0123456789 10
260960 -
260961 - <923k
260962 - Administration Site: Right Port Catheter
260963 - Needle Size: 20 G 1"
260964 - Blood Return Good: Yes
260966 - ..
260967 - Remind patient to call MD if temp > 101 F, Shaking Chills
260968 -
260969 - This protocol differs from Kaiser requirements, reported on
260970 - 041202. ref SDS 49 IX9N
260971 -
260972 -
260973 -
260974 -
2610 -
SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A
3603 -
3604 - 0910
360501 - ..
360502 - Side Effects Consultation Pharmacist Heavy Chest Difficult Breathing
360503 -
360504 - Follow up ref SDS E1 QU8K, ref SDS D8 QU8K.
360506 - ..
360507 - Millie was asked about side effects today, per above. ref SDS 0 QG7K
360508 -
360509 - Rash like acne
360510 -
360511 - Mild condition continues from 070208 around the nose,
360512 - ref SDS C9 QU8K; treatment effective with medication
360513 - prescribed on 070222. ref SDS D8 FO66
360515 - ..
360516 - Face very dry...
360517 -
360518 - Millie notified UCSF in a letter on 070228 of sudden
360519 - extremely dry face, a new side effect of cetuximab.
360520 - ref SDS D9 LR4S The next day, on 070301, Brigid
360521 - prescribed Curel lotion. ref SDS E0 5V73 Since that
360522 - time, treatment with Curel has brought some relief.
360524 - ..
360525 - Lymphedema Cellulitis Complications
360526 -
360527 - Lymphedema continues relatively controlled. There is no
360528 - association with cetuximab treatments, since the
360529 - proximate cause was left breast mastectomy with removal
360530 - of lymph nodes in the left axillar, and is complicated
360531 - by exercise to strengthen the immune system for
360532 - resisting cancer, and by cat bites that flow from
360533 - engaging pets for qualify of life, reported in the case
360534 - study on 070130. ref SDS C4 VX6F
360535 -
360537 - ..
360538 - Tired, fatigued - pulmonary emoblism...
360539 -
360540 - Fatigue, shortness of breath and other symptoms of
360541 - pulmonary embolism were presented during meeting on
360542 - 070130, ref SDS C4 CV5L, citing case study listed on
360543 - 060722. ref SDS 90 ZV41
360545 - ..
360546 - On 070218 Millie notified the primary care physician and
360547 - UCSF that energy continues to recover; she played tennis
360548 - and pulse reached 144. ref SDS D6 N05H
360550 - ..
360551 - Energy that seemed to be declining leading up to
360552 - treatment last week on 070301, ref SDS E1 CA4K, now
360553 - seems to be rising again back to normal this past week.
360554 -
360556 - ..
360557 - Heavy chest - shortness of breathing
360558 -
360559 - Patient history was reported to UCSF on 070130.
360560 - ref SDS C4 RT6I
360561 -
360562 - Condition seems improved, as reported on 070204.
360563 - ref SDS C8 JJ7O No noticable increase, aligns with
360564 - continuing higher energy. ref SDS 0 CA4K
360565 -
360567 - ..
360568 - Cough - clearing throat
360569 -
360570 - This condition seems improved, as reported to the doctor
360571 - on 070130. ref SDS C4 RT6I
360572 -
360574 - ..
360575 - Dry hands and feet...
360576 -
360577 - Dry hands and feet seem much improved since ending
360578 - treatment with Taxotere and capecitiabine on 061201.
360579 -
360581 - ..
360582 - Eyes tearing
360583 -
360584 - This seems improved since ending treatment with Taxoter
360585 - and capecitabine on 061201.
360586 -
360588 - ..
360589 - Nausea and vomitting
360590 -
360591 - Problems with Taxotere and capecitabine reported on
360592 - 061110, ref SDS B2 D19M, did not occur this past week
360593 - after treatment with cetuximab. As a result, there was
360594 - no pre-treatment with Decadron today, per below.
360595 - ref SDS 0 G57I
360597 - ..
360598 - Sores in mouth
360599 -
360600 - None yet, cleaning mouth carefully to avoid problem.
360601 -
360602 -
360603 -
360604 -
3607 -
SUBJECTS
Schedule Treatment Weekly Thursday 0800 4 Week Cycles Clinical Study
3903 -
390401 - ..
390402 - Schedule Weekly Treatments Continue on Thursdays
390403 -
390404 - Follow up ref SDS E1 QK6L, ref SDS D8 QK6L.
390406 - ..
390407 - Millie's next treatment is scheduled for 070315 0830.
390409 - ..
390410 - Since the extra blood test today shows ANC has returned to the normal
390411 - range for treatment with cetuximab, there is no blood test scheduled
390412 - for next week. The normal schedule can be followed of blood tests
390413 - once a month.
390414 -
390415 -
390416 -
390417 -
3905 -
SUBJECTS
Blood Counts ANC Normal 1.51 Test 070308 Safe for Cetuximab 2nd Trea
6003 -
6004 - 0840
600501 - ..
600502 - Blood Counts Normal Full Dose Cetuximab Ordered
600503 - Blood Test Not Scheduled Infusion Clinic Took Approprite Action
600504 -
600505 - Follow up ref SDS E1 Q659, ref SDS D8 Q659.
600506 -
600507 - Millie had a blood test this morning at 0840 in the UCSF Infusion
600508 - Clinic; previous test was on 070301. ref SDS E1 Q659 Last week on
600509 - 070301 ANC was 1.23, well below 1.8 required for safe treatment. The
600510 - doctor approved treatment, but also ordered a follow up test today for
600511 - ANC. This was confirmed in a letter to UCSF and to Kaiser on 070302.
600512 - ref SDS E2 EZ6P
600514 - ..
600515 - When Millie arrived at the Infusion Clinic this morning at 0830, the
600516 - receptionist, Nola, said there was no order for her to get a blood
600517 - test, per above. ref SDS 0 1M6H
600518 -
600519 - [On 070315 similar mistake, UCSF had no record of Millie being
600520 - scheduled for treatment. ref SDS E4 1M6H
600522 - ..
600523 - [On 080403 similar mistake order for blood test delivered to
600524 - the wrong place, ref SDS E9 MQ5F, nurse took immediate action
600525 - relying on experience to provide interim solution while case
600526 - management errors were investigated and corrected. ref SDS E9
600527 - MQ5M
600529 - ..
600530 - Millie explained planning on 070301 for follow up blood testing to
600531 - evaluate ANC in order for Millie to get treatment today. ref SDS E0
600532 - 528F This was confirmed in a letter to UCSF the next day on 070302.
600533 - ref SDS E2 EZ6P Nola took immediate action to schedule a blood test.
600534 - She assigned a nurse to draw blood from Millie's port catheter based
600535 - on the scope for the last blood draw performed 070301. ref SDS E1 OX6L
600537 - ..
600538 - About an hour later results were received from the UCSF laboratory.
600540 - ..
600541 - Case study for the blood test last week on 070301 indicates numerous
600542 - differences with Kaiser's blood test diagnotics with respect to scope,
600543 - units and ranges, further suggesting substantive differences in test
600544 - measurement protocols that effect application to diagnosis and
600545 - treatment, e.g, INR. ref SDS E1 SE6N
600546 -
600548 - ..
600562 - ..
600563 - Log#: 070308 08:40
600564 - <----------------------- U C S F -----------------------> <------------- Kaiser -------------->
600565 - Type Results Units Normal ACRO Type Units Normal
600567 - ..
600568 - PARN CBC with DIFF & PLT CT CBCD
600569 - ..
600570 - WBC COUNT 4.1 x10E9/L 3.4 - 10 WBC WBC x10-3 K/uL 3.4 - 10.0
600571 - RBC COUNT 4.19 x10E12/L 4 - 5.2 RBC RBC x10-6 M/uL 3.60 - 5.70
600572 - HEMOGLOBIN 13.4 g/dL 12 - 15.5 HGB Hemoglobin g/dL 11.5 - 15.0
600573 - HEMATOCRIT 39.4 PERCENT 36 - 46 HCT Hematocrit % 34.0 - 46.0
600574 - MCV 94 fL 80 - 100 MCV MCV fL 80.0 - 100.0
600575 - RDW % 11.9 - 14.3
600576 - MCH 31.9 pg 26 - 34 MCH
600577 - MCHC 33.9 g/dL 31 - 36 MCHC
600578 - PLATELETS 224 x10E9/L 140 - 450 PLT Plt x10-3 K/uL 140 - 400
600579 - ..
600580 - (posted 070307)
600581 - CA 15-3 No Report U/mL < 31 CA15-3 CA 15-3 < 39
600583 - ..
600584 - NEUTS L 1.51 x10E9/L 1.8 - 6.8 N-A ANC 1500
600585 - Neutrophils Not Reported Neutrophils % 50 - 70
600587 - ..
600588 - LYMPHS 1.89 x10E9/L 0.9 - 2.9 L-A Lymphocytes % 20 - 50
600589 - MONOS 0.34 x10E9/L 0.1 - 0.6 M-A Monocyte % 0 - 11
600590 - EOS 0.32 x10E9/L 0 - 0.4 E-A Esoinophils % 1 - 5
600591 - BASOS 0.07 x10E9/L 0 - 0.1 B-A Basophil % 0 - 2
600592 - Bands % 0 - 5
600593 - Bands % 0 - 5
600594 - Bands % 0 - 5
600595 - ******************* End of Report *********************
600596 - Leave this part as form for next test
600597 - ******************* End of Report *********************
600598 - ..
600599 - <----------------------- U C S F -----------------------> <------------- Kaiser -------------->
600600 - Type Results Units Normal ACRO Type Units Normal
600602 - ..
600603 - PT H 28.0 S 12.5 - 16.0 PT PT, patient sec 8.9 - 11.1
600604 - INL Nrm Ratio H 2.5 0.9 - 1.2 INR PT INR sec 2.0 - 3.0
600605 - PARTIAL
600606 - THROMBOPLASTIN 31.7 S 22.4 - 33.3 PTT
600608 - ..
600609 - ELECTROLYTE PANEL LYTE
600610 - SODIUM 140 mmol/L 134 - 143 NA Sodium mEq/L 137 - 145
600611 - POTASSIUM 4.0 mmol/L 3.4 - 4.9 K Potassium mEq/L 3.5 - 5.3
600612 - CHLORIDE 105 mmol/L 98 - 107 CL
600613 - CARBON DIOX TOTAL 27 mmol/L 23 - 32 CO2
600614 - ANION GAP 8 3 - 14 ANGA
600616 - ..
600617 - UREA NITROGEN 12 mg/dL 8 - 23 BUN BUN mg/dL 7 - 17
600618 - CALCIUM 9.4 mg/dL 8.7 - 10.1 CA Calcium mg/dL 8.4 - 10.2
600619 - MAGNESIUM 2.0 mg/dL 1.8 - 2.3 MG Magnesium mg/dL 1.6 - 2.3
600621 - ..
600622 - CREATININE 0.7 mg/dL 0.6 - 1.2 CR Creatinine mg/dL 0.6 - 1.2
600623 - AST 36 U/L 16 - 41 AST AST (SGOT) U/L 14 - 36
600624 - ALT 24 U/L 11 - 54 ALT ALT (SGPT) U/L 11 - 66
600625 - BILIRUBIN TOTAL 0.7 mg/dL 0.3 - 1.3 BILT Bili Total mg/dL 0.2 - 1.3
600626 - ALKALINE PHOSPHATASE 53 U/L 29 - 111 ALKP Alkaline Ph U/L 38 - 126
600627 - PROTEIN TOTAL 6.2 g/dL 5.8 - 8.0 TP Protein, Total g/dL 6.3 - 8.2
600628 - ALBUMIN 4.0 g/dL 3.4 - 4.7 ALB Albumin g/dL 3.4 - 4.8
600629 -
600630 -
600631 -
600632 -
6007 -
SUBJECTS
Coagulation Control Coumadin Treatment Pulmonary Embolism INR 2.5 PT
6703 -
670401 - ..
670402 - Coagulation Control INR 2.5 Normal Stable PT 28 High
670403 -
670404 - Follow up ref SDS E1 SE6N, ref SDS D8 SE6N.
670405 -
670406 - On 070302 Gloria at Kaiser's Coagulation Control Clinic in Martinez
670407 - left a message for Millie to get a blood test for INR today.
670408 - ref SDS E2 U24Y
670410 - ..
670411 - Millie responded in a letter to Kaiser, with a copy to Jackie at UCSF,
670412 - that since the doctor ordered a follow up blood test today to evaluate
670413 - low ANC last week, that INR could be tested again this week, per
670414 - Gloria's request. ref SDS E2 X84G
670416 - ..
670417 - For some reason, UCSF did not order the blood test this morning, per
670418 - above, ref SDS 0 JG4G, and when the nurse initiated an order based on
670419 - Millie's report of the Doctor's plan for a follow up blood test today
670420 - to assess ANC, a test for INR was not included, as shown in results of
670421 - the test. ref SDS 0 075H
670423 - ..
670424 - Since INR was 2.5 for several weeks in a row, skipping INR test until
670425 - the next blood test for the clinical study on 070329 was planned on
670426 - 070302. ref SDS E2 X84G Subsequently, on 070307 Gloria seemed to
670427 - concur with this planning. ref SDS E3 IY6I
670428 -
670429 -
670430 -
670431 -
6705 -
SUBJECTS
Absolute Neutrophils Count ANC 1510 Below 1800 UCSF Criteria But Abo
8103 -
810401 - ..
810402 - ANC 1510 Below 1800 Criteria for Blood Counts to Approve Treatment
810403 -
810404 - Follow up ref SDS E1 P560, ref SDS D8 P560.
810405 -
810406 - Background on differences representing ANC in Kaiser and UCSF blood
810407 - testing is reported on 070301. ref SDS E1 U37I
810408 -
810409 - <----------------------- U C S F -----------------------> <------------- Kaiser -------------->
810410 - Type Results Units Normal ACRO Type Units Normal
810412 - ..
810413 - NEUTS L 1.51 x10E9/L 1.8 - 6.8 N-A ANC 1500
810414 - Neutrophils Not Reported Neutrophils % 50 - 70
810416 - ..
810417 - ANC begins to rise...
810418 -
810419 - 6972................................ 060814, ref SDS 98 P560
810420 - 6390................................ 060908, ref SDS A1 P560
810421 - 5200................................ 060929, ref SDS A3 P560
810422 - 3869................................ 061020, ref SDS A8 P560
810423 - 2880................................ 061110, ref SDS B2 P560
810424 - 2888................................ 061201, ref SDS B4 P560
810425 - 1760................................ 070201, ref SDS C6 P560
810426 - 1230................................ 070301, ref SDS E1 P560
810427 - 1510................................ 070308, ref SDS E0 P560
810429 - ..
810430 - The nurse indicated that ANC 1510 in the blood test today, ref SDS 0
810431 - QY6H, meets the criteria for > 1500 that makes chemotherapy treatment
810432 - save with cetuximab. This is the first rise in ANC in over 6 months.
810434 - ..
810435 - This resolves concern during the meeting with Doctor Rugo on 070301,
810436 - when the decison was made to give treatment with ANC 1.23, well below
810437 - the safe range for treatment, ref SDS E0 3K6H, and reviewed again this
810438 - morning, per above. ref SDS 0 CJ3I
810439 -
810440 -
810441 -
810442 -
810443 -
810444 -
8105 -
SUBJECTS
Blood Tests CA 15-3 36 Test 070301 Results Submitted by UCSF CA 15-3
8603 -
860401 - ..
860402 - CA 15-3 36 Tests 2 From Kaiser 1 from UCSF Pending Submission
860403 -
860404 - Follow up ref SDS E1 2N5J, ref SDS D8 2N5J.
860405 -
860406 - CA 15-3 was not tested with the blood draw today. This was done last
860407 - week on 070301, however, results of the test were not available at
860408 - that time. ref SDS E1 2N5J During the meeting with Doctor Rugo,
860409 - Jackie related UCSF policy to test CA 15-3 monthly. ref SDS E0 N95M
860411 - ..
860412 - Yesterday, on 070307 Kaiser submitted results on blood tests for
860413 - February, showing consecutive declines, ref SDS E3 9Z9N; and UCSF
860414 - reported the test last week on 070307 showed a dramatic drop in CA
860415 - 15-3 to 36, the lowest in over a year. ref SDS E3 U85L
860416 -
860417 -
860418 -
860419 -
860420 -
8605 -
SUBJECTS
Port Catheter IV Connection Prepare for Drip Treatment 1 Try Require
9003 -
9004 - 1045
900501 - ..
900502 - Preparation for Treatment Required One (1. Attempt to Connect Port
900503 -
900504 - Follow up ref SDS E1 EB7J, ref SDS D8 EB7J.
900506 - ..
900507 - The nurse connected the IV tubes to the port....
900509 - ..
900510 - Interlink System Vented Paclitaxel set
900512 - ..
900513 - Like last week on 070301, there were no problems getting blood to flow
900514 - from the port, ref SDS E1 EB7J, as occurred on 070222, ref SDS D7
900515 - DC5W, and earlier on 070201. ref SDS C6 DC5W
900517 - ..
900518 - The nurse flushed the port with saline.
900519 -
900520 -
900521 -
900522 -
9006 -
SUBJECTS
Blood Draws 7 Vials Clinical Study Research Cetuximab Drug Trial Blo
9403 -
940401 - ..
940402 - Blood Draws 7 Vials for Clinical Study Research
940403 -
940404 - Follow up ref SDS E1 O56V, ref SDS D8 O56V.
940405 -
940406 - There were no blood draws today, because the study requires blood for
940407 - research only at the beginning of each cycle, and this is the 2nd
940408 - treatment in the 2nd cycle.
940409 -
940410 -
940411 -
940412 -
940413 -
9405 -
SUBJECTS
Benadryl Pre-treatment Prepares Patient for Cetuximab Chemotherapy A
9603 -
9604 - 1050
960501 - ..
960502 - Benedryl Reduce Side Effects Cetuximab Chemotherapy Treatment
960503 -
960504 - Follow up ref SDS E1 DC7J, ref SDS D8 DC7J.
960505 -
960506 - Benadryl (diphenhydramine) started. 50 MG....... ref SDS 0 IJ41
960507 -
960508 - Purpose reported on 060721. ref SDS 89 DC7J
960510 - ..
960511 - Chemotherpay order calls for Benadryl (diphenhydramine) pre-treatment
960512 - 30 - 60 minutes prior to cetuximab infusion, shown below. ref SDS 0
960513 - IJ41
960514 -
960516 - ..
9606 -
9607 -
9608 - 1103
9609 -
960901 - Benedryl completed equipment beeps.
960902 -
960903 -
960905 - ..
9610 -
9611 -
9612 -
9613 -
961301 - Decadron (dexamethasone) IV pre-treatment........ ref SDS 0 FM4M
961302 -
961303 - On 070208 Decadron was not given because Millie did not experience
961304 - side effects of nausea and vomitting after treatment with cetuximab on
961305 - 070201. ref SDS C9 G57I Since this favorable condition continues, per
961306 - above, ref SDS 0 D19M, Decadron was not given again today.
961307 -
961308 -
961310 - ..
9614 -
9615 -
9616 -
9617 -
961701 - Decadron completed -- not reported.
961702 -
961703 -
961704 -
961705 -
9618 -
SUBJECTS
Cetuximab 2nd Cycle 2nd Treatment Clinical Study Drug Trial Treatmen
9803 -
9804 - 1120
980501 - ..
980502 - Cetuximab Full Dose Blood Counts on Targets Treatment 1 Hour
980503 -
980504 - Follow up ref SDS E1 4N5M, ref SDS D8 4N5M.
980505 -
980506 - Cetuximab started.
980507 -
980508 - Verify chemotherapy order for 070208.
980510 - ..
980511 - Chemotherapy Orders...
980512 -
980518 - Auth# Stor BCC LOC
980519 - Visit: 12575738 DOS 20070201
980521 - ..
980522 - Date: 20070201
980524 - ..
980525 - Study Order for CC#05752: Phase II Trial of Cetuximab alone and
980526 - in combination with Carboplatin in ER-negative, PR-negative,
980527 - HER2-negative Nonoverexpressing Metastatic Breast Cancers
980529 - ..
980530 - Dates to be given: 070201
980531 - Arm 1:Cetuximab alone
980533 - ..
980534 - Diagnosis: breast cancer
980536 - ..
980537 - ICD-9 codes: 174.9
980538 - Allergies NKDA
980540 - ..
980541 - Pre-medications 30 - 60 minutes prior to cetuximab infusion
980543 - ..
980544 - 3. Diphenhydramine 50 mg IV or [illegible writing]
980546 - ..
980547 - 4. Dexamethasone (??) 10 mg IB or 20 mg IV [handwritten ???]
980548 -
980549 - Further premed TBD [barely legible handwriting??]
980551 - ..
980552 - Medication: (plan to give weekly ********STUDY SUPPLY**********
980554 - ..
980555 - 5. Cetuximab (Erbitux) (loading dose)
980556 -
980557 - 400 mg/m [squared] = 684 mg IV over 120 minutes for
980558 - first dose x 1
980559 -
980560 - dose on dcte 20070201 Maximum infusion rate is 5 ml/minute
980561 - (concentration 2 mg/ml)
980563 - ..
980564 - 6. Cetuximab (Erbitux) (maintenance dose)
980565 -
980566 - 250 mg/m [squared] = 428 mg IV (or ____ mg/m[squared] =
980567 - ____mg) IV over 60 or ____ minutes.
980568 -
980569 - Maximum infusion rate is 5 ml/minute (concentration 2 mg/ml)
980570 - Infuse once weekly for 8 weeks. First dose to be given on date
980571 - 20070201.
980573 - ..
980574 - Cetuximab is administered undiluted through a low protien
980575 - binding 0.22 micro in-line filter. Use NS solution to flush the
980576 - line at the end of the infusion.
980578 - ..
980579 - ARM 2: Administer carboplatin of vital signs are unremarkable
980580 - one hour after cetuximab infusion.
980582 - ..
980583 - Vital signs at baseline, upon cetuximab completion and one hour
980584 - after cetuximab.
980585 -
980586 - ****please note start and stop times****
980588 - ..
980589 - Laboratory work:
980590 -
980591 - See carboplatin orders
980593 - ..
980594 - x Notify MD for dose modifications if patient has severe
980595 - acne in form rash
980596 -
980597 - CBC with differential and platletes every 4 weeks
980598 - Creatinine and magnesium every 4 weeks
980599 - BUN AST Alk phos Alt Total bilrubin, electrolyes every 8
980600 - weeks. If levels are outside of normal laboratory values
980601 - notify Brigid NP (MD/RN) at 415 443 4730
980603 - ..
980604 - x Physician has discussed risks/benefits of therapy with the
980605 - patient. Signed consent obtained.
980606 -
980607 -
980608 - Yes No O2 by nasal cannula at 2 liters/min prn for chest
980609 - pain or SOB
980611 - ..
980612 - Yes No Diphenhydramine 50 mg IV prn x1 for urticaria
980613 - [barely legible], pruritis SOB
980615 - ..
980616 - Yes No Hydrocortizone 100 mg IV prn x1 for urticaria
980617 - [barely legible], pruritis SOB
980619 - ..
980620 - Yes No Albuterol inhaler 2-4 puffs prn SOB or chest
980621 - tightness
980623 - ..
980624 - Yes No Epinephrine 1x1000 (1 mg/ml) 0.3 mg IV prn
980625 - anaphylaxis
980627 - ..
980628 - Breast CC05752 Cetuximab doc 20061024
980629 - Approved 20060615
980631 - ..
980632 - Physician signature [Hope Rugo]
980634 - ..
980635 - Provider# 35313
980637 - ..
980638 - Date: 20010131
980639 -
980641 - ..
9807 -
9808 -
9809 - 1230
9810 -
981001 - Cetuximab treatment completed.
981002 -
981003 - Millie had a 1 hour rest and observation period.
981005 - ..
981006 - The nurse was not aware of this requirement.
981008 - ..
981009 - Millie explained the protocol for her cetuximab treatments, per above.
981010 - ref SDS 0 G679
981011 -
981012 -
981014 - ..
9811 -
9812 -
9813 - 1330
9814 -
981401 - The nurse disconnected the IV tubes.
981403 - ..
981404 - She inserted Herceptin to flush the port.
981406 - ..
981407 - She then removed the needle from the port, and swabbed the needle
981408 - wound, and placed a temporary bandage.
981409 -
981410 -
981411 -
981412 -
981413 -
9815 -
SUBJECTS
Vitals Blood Pressure Pulse Temperature Sa02 Weight Infusion Treatme
A103 -
A104 - 1100
A10501 - ..
A10502 - Vitals Show Patient Stable
A10503 -
A10504 - Follow up ref SDS E1 AW4L, ref SDS D8 AW4L.
A10505 -
A10506 - Since Catherine was not assigned today, for some reason protocol
A10507 - requirements for takeing vitals 3 times, per above, ref SDS 0 G679,
A10508 - were not followed today...
A10509 -
A10510 - Blood
A10511 - Date Time Pressure Pulse Temprtr Weight So2
A10513 - ..
A10514 - 070308 1100..... 144 87 70 36.0c 98
A10515 - 070301 1645..... 125 62 90 * 36.4c
A10516 - 070301 1505..... 112 69 86 * 36.6c 98
A10517 - 070222 1145..... 115 73 58 36.3c 147 98
A10518 - 070222 1045..... 100 60 56 36.6c 147 98
A10519 - 070222 0930..... 117 63 68 36.2c 147 97
A10520 - 070215 1200..... 106 66 61 37.0c 147 97
A10521 - 070215 1055..... 96 61 64 37.0c 147 94
A10522 - 070215 0930..... 100 64 66 36.7c 147 98
A10523 - 070208 0920..... 143 70 59 36.5c 147 98
A10524 - 070201 1330..... 136 74 66 148 94
A10525 - 070201 1220..... 110 65 62 36.3c 148 96
A10526 - 070201 1000..... 132 80 65 36.9c 148 99
A10527 - 061201 1534..... 123 76 76 97.5 150
A10528 - 061110 1534..... 136 83 73 97.0 150 98
A10529 - 061020 1534..... 140 79 67 99.8 151 97
A10530 - 060929 1452..... 141 78 66 98.3 149
A10531 - 060908 1335..... 139 79 73 98.1 149
A10532 - 060814 1610..... 139 80 59 98.2 151
A10533 - 060722 1440..... 142 74 67 98.1 149
A10534 - 060711.......... 172 87 54 97.5 147
A10535 - 060623.......... 141 87 71 98.0 147
A10536 - 060428.......... 129 73 80 99.4 149
A10537 - 060217.......... 153 81 61 98.6 150
A10538 - 050916.......... 120 80 80 98.5
A10539 -
A10540 - * Need vitals taken twice to verify atypical diagnostics.
A10541 -
A10542 -
A10543 -
A10544 -
A106 -
SUBJECTS
Energy Normal Stable Alert Drive Home After Treatment IBC 3rd Relaps
A403 -
A404 - 1330
A40501 - ..
A40502 - Energy Normal Stable After Treatment Cetuximab Support Drugs
A40503 -
A40504 - Follow up ref SDS E1 F54N, ref SDS D8 F54N.
A40506 - ..
A40507 - On 060724 diary side effects for cetuximab chemotherapy treatment on
A40508 - clinical study drug trial. ref SDS 92 YP4I
A40510 - ..
A40511 - Millie reported side effects of low energy, and fatigue reported last
A40512 - week have begun to recover; she feels strong today, per above.
A40513 - ref SDS 0 FG3N
A40515 - ..
A40516 - Millie was alert after treatment again today, and not wobbly nor
A40517 - disoriented. She was able to drive home without side effects of
A40518 - treatment.
A40519 -
A40520 -
A40521 -
A40522 -
A40523 -
A40524 -
A40525 -
A40526 -
A40527 -
A406 -