CONTACTS 

SUBJECTS
Cetuximab Carboplatin Clinical Study 2nd Arm 7th Cycle 1st Treatment

1003 -
1003 -    ..
1004 - Summary/Objective
1005 -
100501 - Follow up ref SDS N3 0000. ref SDS M6 0000.
100502 -
100503 -
100504 -
100505 -
100506 -
100508 -  ..
1006 -
1007 -
1008 - Progress
1009 -
100901 - Background on Millie's treatment in the clinical study is reported on
100902 - 080508. ref SDS A1 TZ8I
100904 -  ..
100905 - Treatment on the cetuximab Carboplatin clinical study was stopped by
100906 - Doctor Rugo on 081023, ref SDS K0 D65G, after 90 treatments with
100907 - cetuximab, and 21 treatments with Carboplatin on the 2nd arm of the
100908 - study. ref SDS J8 V94O
100910 -  ..
100911 - On 081016 Doctor Rugo proposed treating Millie with a clinical study
100912 - for sunitinib metronomic (low dose) protocol, that includes
100913 - cyclophosmphamide and Methotrexate. ref SDS J0 J38U  At that time, a
100914 - work plan was developed on 081016. ref SDS J0 J36R
100916 -  ..
100917 - Work plan was updated on 081029. ref SDS K6 LH4O
100919 -  ..
100920 - The sunitinib protocol requires daily oral treatment, and began on
100921 - 081114. ref SDS L2 505G  Millie takes these drugs in the mornings at
100922 - 0700, reported in another record today. ref SDS L4 505G
100924 -  ..
100925 - Background on transitioning to sunitinib is reported on 081107.
100926 - ref SDS K9 4F6G
100928 -  ..
100929 - On 081113 Millie had a blood draw for study tubes only to start the
100930 - new treatment with sunitinib; no lab reports were done, she was
100931 - welcomed back to the Infusion Clinic by the regular Thursday staff.
100932 - ref SDS L1 WV62
100934 -  ..
100935 - Sunitinib treatment started on 081114 for 2 weeks to evaluate
100936 - effectiveness, and tolerance of side effects. ref SDS L2 505G
100938 -  ..
100939 - The full sunitinib treatment protocol was begun 2 weeks later on
100940 - 081128. ref SDS L8 505G
100942 -  ..
100943 - On 090122 the doctor ended Millie's treatment with sunitinib due to
100944 - progression of disease, and rising side effects were difficult to
100945 - tolerate.
100946 -
100947 -
100948 -
100949 -
100950 -
100951 -
1010 -

SUBJECTS
Default Null Subject Account for Blank Record

1703 -
170401 -  ..
170402 - Schedule Blood Draws to Perform Laboratory Tests Sunitinib Treatment
170403 -
170404 - Follow up ref SDS N3 1K7H, ref SDS M6 1K7H.
170406 -  ..
170407 - Neupogen scheduled through 090131 is listed on 081220. ref SDS M9 HS5M
170409 -  ..
170410 - Sunitinib is a "targeted" cancer treatment that has less effect on
170411 - blood counts.  Cyclophosphamide and Methotrexate are chemotherapy
170412 - drugs that reduce blood counts.  These drugs created problems for
170413 - Millie to maintain drug counts, reviewed with the medical team at UCSF
170414 - on 081218, ref SDS M7 QW7H  As a result, Doctor Rugo approved Neupogen
170415 - treatments on 081219 and 081220, ref SDS M9 P73J, and further paused
170416 - Millie's treatments entirely for a week, and eliminated Methotrexate
170417 - from the treatment protocol. ref SDS M7 QW49
170419 -  ..
170420 - Blood test on 081226 after pausing cancer treatment for a week showed
170421 - significant increase in blood counts. ref SDS N0 OT8J
170423 -  ..
170424 - As a result, Millie's treatment with sunitinib resumed on 081227 at
170425 - full strength, along with cyclophosphamide, reported to the medical
170426 - team on 081230. ref SDS N1 JV5M
170428 -  ..
170429 - Case study on blood tests and dilemma maintaining blood counts in
170430 - order to continue with cancer treatments is reported on 081230.
170431 - ref SDS N1 I87N
170433 -  ..
170434 - Three (3) week cycles sunitinib protocol requires blood draws and
170435 - meetings with the medical team as follows...
170437 -  ..
170438 - During the meeting with the medical team, Glenna confirmed times for
170439 - meetings through 090402...
170441 -  ..
170442 - We need Nola to confirm times for Millie's blood draws.  She was not
170443 - in the office during Millie's blood draw at 0800 this morning.
170445 -  ..
170446 - On 090108 Glenna submitted schedule for meetings with the doctor.
170447 - ref SDS N4 UY3Y
170449 -  ..
170450 - On 090115 Millie submitted a letter to Catherine and Diane asking for
170451 - assistance getting blood tests scheduled at UCSF. ref SDS N5 485J
170453 -  ..
170454 - On 090121 Nola advised that Millie has been scheduled for blood draws
170455 - as shown in the record today on 090108. ref SDS N7 N57I
170456 -
170458 -     ..
170459 -    Date  Time   Staff         Sta  Type  Dept   Loc  Dur  Number  Cycl
170460 -
170461 -    Follow up ref SDS N3 PN6F, ref SDS M6 PN6F.
170462 -
170463 -    090129 0800  Catherine    PEN  AC1  CCINF  INF  20            04
170464 -    090129 0830  Rugo         PEN  CHF  BCC    Z4F  30            04
170465 -                 Tara
170466 -                 Glenna
170467 -    090219 0800  Catherine    PEN  AC1  CCINF  INF  20            05
170468 -    090219 0900  Rugo         PEN  CHF  BCC    Z4F  30            05
170469 -                 Tara
170470 -                 Glenna
170471 -    090312 0800  Catherine    PEN  AC1  CCINF  INF  20            06
170472 -    090312 0830  Rugo         PEN  CHF  BCC    Z4F  30            06
170473 -                 Tara
170474 -                 Glenna
170475 -    090402 0800  Catherine    PEN  AC1  CCINF  INF  20            07
170476 -    090402 0830  Rugo         PEN  CHF  BCC    Z4F  30            07
170477 -                 Tara
170478 -                 Glenna
170479 -    090423 0800  Catherine    PEN  AC1  CCINF  INF  20            08
170480 -    090423 0830  Rugo         PEN  CHF  BCC    Z4F  30            08
170481 -                 Tara
170482 -                 Glenna
170483 -    090514 0800  Catherine    PEN  AC1  CCINF  INF  20            09
170484 -    090514 0830  Rugo         PEN  CHF  BCC    Z4F  30            09
170485 -                 Tara
170486 -                 Glenna
170487 -    090604 0800  Catherine    PEN  AC1  CCINF  INF  20            10
170488 -    090604 0830  Rugo         PEN  CHF  BCC    Z4F  30            10
170489 -                 Tara
170490 -                 Glenna
170491 -
170492 -
170493 -
1705 -

SUBJECTS
Blood Tests Labs Infusion Clinic Evaluate Safe Chemotherapy 1st Trea

2503 -
2504 - 0750
250501 -  ..
250502 - Labs Blood Test
250503 -
250504 - Follow up ref SDS N3 FW5N, ref SDS M6 FW5N.
250506 -  ..
250507 - On 081113 Millie had a blood draw for study tubes only to start the
250508 - new treatment with sunitinib; no lab reports were done. ref SDS L1
250509 - WV62  The prior labs for the sunitinib study were done on 081107.
250510 - ref SDS K9 LO4G
250512 -  ..
250513 - On 081126 Millie had a blood draw to start the first full cycle of the
250514 - study.  On 081203 Millie had a blood draw at Kaiser to evaluate
250515 - concerns about low blood counts, with results reported on 081205.
250516 - ref SDS M3 CT3K  Case study at that time showed blood counts fell to
250517 - lowest in Millie's patient history, ref SDS M3 EC5N, and aligned with
250518 - rising symptoms of fatigue, muscle weakness, and low vitality and
250519 - vigor associated with chemotherapy, which Glenna reported on 081203
250520 - was also occurring with other patients on the sunitinib protocol.
250521 - ref SDS M2 673J  On 081210 she had a blood draw to test NEUTS for
250522 - getting Neupogen. ref SDS M4 S65I  There was a follow up lab at Kaiser
250523 - on 081212. ref SDS M5 S65I
250525 -  ..
250526 - Millie's last blood draw was at Kaiser on 090122 while being treated
250527 - in the Emergency Department for a dislocated shoulder.  The lab on
250528 - 090122 was not a full lab, and so NEUTS could not be calculated;
250529 - however WBC 8.6 was significantly elevated compare to patient history
250530 - the past 3 - 4 years. ref SDS N8 OT8J
250532 -  ..
250533 - The most recent full lab was at Kaiser on 090116 when NEUTS 1.768 was
250534 - reported. ref SDS N6 B35J  The previous lab at UCSF was on 090108; at
250535 - that time NEUTS 0.87 was below the target level, ref SDS N3 QY6H, and
250536 - resulted in prescribing Neupogen treatment, and pausing
250537 - cyclophosphamide in the sunitinib clinical study protocol. ref SDS N3
250538 - EO5I
250540 -  ..
250541 - Catherine was Millie's nurse today for the blood draw...
250542 -
250557 -     ..
250558 -    Log#:                   090129 08:15
250559 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
250560 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
250561 -     ..
250562 -    CBC with DIFF & PLT CT                                     CBCD
250563 -     ..
250564 -    WBC COUNT               4.1    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
250565 -    RBC COUNT      l        2.78   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
250566 -    HEMOGLOBIN     l        9.6    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
250567 -    HEMATOCRIT     l       28.0    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
250568 -    MCV            h      101      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
250569 -    MCH            h       34.6    pg           26  -   34     MCH
250570 -    MCHC                   34.4    g/dL         31  -   36     MCHC
250571 -     ..
250572 -    PLATELETS             190      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
250573 -    ..
250574 -       (posted 090205, Catherine)
250575 -    CA 15-3        h      113      U/mL             <  33     CA153  CA 15-3                        <  39
250576 -
250577 -         Note new reference range [<33 changed from <31] and change in
250578 -         methodology effective March 1, 2008.  Performed using the
250579 -         Siemens Centaur Chemiluminesence method.  CA 15-3 result using
250580 -         the Roche Elecsys assay is 75 U/mL.  Ref range <31 U/mL.  This
250581 -         rebaseline value provided at no additional charge.
250583 -          ..
250584 -         This new note updates explanation of tests prior to 080301,
250585 -         e.g., on 080207. ref SDS 74 A16M
250586 -    ..
250587 -     (NEUTS x 1000 = ANC for Kaiser)
250588 -    NEUTS          L        1.76   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
250589 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
250591 -     ..
250592 -    LYMPHS                  1.19   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
250593 -    MONOS                   0.27   x10E9/L     0.2  -  0.8     M-A   Monocyte          %         0  -  11
250594 -    EOS              h      0.80   x10E9/L     0.0  -  0.4     E-A   Esoinophils       %         1  -  5
250595 -    BASOS                   0.07   x10E9/L     0.0  -  0.1     B-A   Basophil          %         0  -  2
250596 -     ..
250597 -  * LUC/ATYP LYMPHS  [No report]   x10E9/L     0.0  -  0.2     LALA
250599 -     ..
250600 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
250601 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
250602 -    PT              h      27.7    s          12.0  -  14.1    PT    PT, patient       sec     8.9  -  11.1
250603 -    INL NRM Ratio   h       2.5                0.9  -  1.1     INR   INR                       2.0  -  3.0
250604 -
250605 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
250606 -        Francisco, CA  94115
250608 -     ..
250609 -  * PARTIAL
250610 -    THROMBOPLASTIN  H [No report]  s          22.2  - 34.2     INR   PTT
250611 -
250612 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
250613 -        Francisco, CA  94115
250615 -     ..
250616 -  * FIBRINOGEN        [No report]  mg/dL       202  - 430      FIB
250617 -
250618 -        New test added today, 080818; Catherine says similar to INR.
250620 -     ..
250621 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
250622 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
250623 -    ELECTROLYTE PANEL                                          LYTE
250624 -    SODIUM                139      mmol/L      134  -  143     NA    Sodium            mEq/L   137  -  145
250625 -    POTASSIUM               4.2    mmol/L      3.4  -  4.9     K     Potassium         mEq/L   3.5  -  5.3
250626 -    CHLORIDE              103      mmol/L       98  -  107     CL
250627 -    CARBON DIOX TOTAL      26      mmol/L       23  -  32      CO2
250628 -    ANION GAP              10                    3  -  14      ANGA
250629 -     ..
250630 - *  UREA NITROGEN          14      mg/dL         8  -  23      BUN   BUN               mg/dL     7  -  17
250631 -    GLUCOSE       [No report]      mg/dL        70  -  199     GLU   Glucose           mg/dL     ?  -   ?
250632 -    AST            h       48      U/L          16  -  41      AST   AST (SGOT)        U/L      14  -  36
250633 -    ALT                    24      U/L          11  -  54      ALT   ALT (SGPT)        U/L      11  -  66
250634 -    BILIRUBIN, TOTAL        0.7    mg/dL       0.3  - 1.3      BILT  Bili Total        mg/dL   0.2  - 1.3
250635 -    ALKALINE PHOSPHATASE   50      U/L          29  - 111      ALKP  Alkaline Ph       U/L      38  - 126
250636 -     ..
250637 -    PROTEIN, TOTAL [No report]     g/dL        5.8  - 8.0      TP    Protine Total     g/dL    6.3  - 8.2
250638 -    ALBUMIN        [No report]     g/dL        3.4  - 4.7      ALB   Albumin           g/dL    3.4  - 4.8
250639 -    CALCIUM        [No report]     mg/dL       8.7  - 10.1     CA    Calcium           mg/dL   8.4  - 10.2
250640 -     ..
250641 -    MAGNESIUM      [No report]     mg/dL       1.8  -  2.3     MG    Magnesium         mg/dL   1.6  -  2.3
250642 -    PHOSPHORUS     [No report]     mg/dL       2.4  -  4.6     PO4   Phosphorus
250644 -     ..
250645 -    CREAT with eGFR
250646 -    CREATININE              0.61   mg/dL      0.42  - 1.06     CR    Creatinine        mg/dL   0.6  -  1.2
250647 -
250648 -      Note: Creatinine assay changed to IDMS standardization on
250649 -      February 4, 2008 causing decrease in results of approximately
250650 -      0.09 mg/dL
250652 -     ..
250653 -    eGFR if Caucasian     >60      mL/min                      GFRC
250654 -    eGFR if African Amer  >60      mL/min                      GFRA
250655 -
250656 -      eGFR corrected for 1.73 sq meters of body surface area
250657 -      Note:  eGFR is only an estimation. Please see online Lab Manual
250658 -      for potential limitations.
250659 -      Performed at Mt Zion Clin Lab, 1600 Divisadero, San Francisco,
250660 -      CA  94115
250662 -     ..
250663 - *  Labs today 081023 included tests omitted on 081016 labs...
250664 -
250665 -            LUC/ATYP LYMPHS...................... ref SDS I9 Z47G
250667 -     ..
250668 -    Labs today 081023 omitted tests included on 081016 labs...
250669 -
250670 -            PARTIAL THROMBOPLASTIN............... ref SDS J8 GQ6F
250672 -     ..
250673 -    Labs included on 081016 tests omitted on 080918 labs...
250674 -
250675 -            LUC/ATYP LYMPHS...................... ref SDS I9 Z47G
250677 -     ..
250678 -    Labs omitted tests on 081016 included on 080918 labs...
250679 -
250680 -            PARTIAL THROMBOPLASTIN............... ref SDS H4 GQ6F
250681 -            FIBRINOGEN........................... ref SDS H4 VE6I
250683 -     ..
250684 -    Labs on 080821 omitted following tests...
250685 -
250686 -            GLUCOSE.............................. ref SDS F7 SE9J
250687 -            ALBUMIN.............................. ref SDS F7 GT9I
250688 -            PROTEIN, TOTAL
250690 -     ..
250691 -    Labs on 080726 omitted following tests...
250692 -
250693 -            GLUCOSE.............................. ref SDS D9 SE9J
250694 -            ALBUMIN.............................. ref SDS D9 GT9I
250696 -     ..
250697 -    Labs on 080626 omitted following tests...
250698 -
250699 -            GLUCOSE.............................. ref SDS B8 HS7I
250700 -            PROTEIN, TOTAL
250701 -            ALBUMIN
250702 -            CALCIUM
250704 -  ..
250705 - Case study on 080626 shows these four tests, which have been omitted
250706 - and included in various combinations the past 4 cycles, were
250707 - consistently included for the prevous 15 cycles. ref SDS B8 HS8F
250708 -
260427 -
260428 -
2605 -

SUBJECTS
Absolute Neutrophils Count ANC 6850 Above 1500 NEUTS 6.85 Above 1.5

3503 -
350401 -  ..
350402 - NEUTS 0.87 Decrease Significant from Cheotherapy Sunitinib 2 Weeks
350403 - Blood Counts NEUTS 0.87 Fall With Cyclophosphamide Sunitinib 2 Weeks   Weeks
350404 -
350405 - Follow up ref SDS N3 PU6K, ref SDS M6 PU6K.
350406 -
350407 - Blood counts decreased significantly shown by the Lab report today
350408 - with NEUTS 0.87, ref SDS N3 QY6H, compared with NEUTS 1.71 (ANC 1710) 2
350409 - weeks ago at Kaiser on 081226, ref SDS N0 B35J, This is below the UCSF
350410 - range of 1.00 for Millie to safely get chemotherapy treatment.
350412 -  ..
350413 - Blood counts decline from...
350414 -
350415 -                     1710 to 870    = 640 points
350416 -
350417 -                   081226 to 090108 = 12 days
350418 -
350419 -      Blood counts average decline  = 53 per day
350421 -  ..
350422 - Previously, on
350424 -  ..
350425 - Side effects of Neupogen are listed below. ref SDS I9 SB8I
350427 -  ..
350428 - The doctor prescribed Neupogen tomorrow and Saturday (090109 and
350429 - 090110) at Kaiser, and also paused treatment with cycolphosphamide
350430 - chemotherapy until NEUTS rise to 1.00.  This will be tested with
350431 - another blood draw at Kaiser on 090116.
350432 -
350433 -
350434 -
350435 -
3505 -

SUBJECTS
Default Null Subject Account for Blank Record

3603 -
360401 -  ..
360402 - Side Effects Neupogen Treatments Continue Mild Tolerance Acceptable
360403 -
360404 - Follow up ref SDS N3 SB8I, ref SDS M6 SB8I.
360405 -
360406 - Fitness from hiking is listed in case study on 081021. ref SDS J5 8G5M
360408 -  ..
360409 - Millie last reported side effects on 081011 experiencing bone pain,
360410 - headache, and fatigue associated with Neupogen and chemotherapy.
360411 - ref SDS I4 FL4H
360413 -  ..
360414 - Side effects of Neupogen may be lessening, reported on...
360415 -
360416 -               081011................, ref SDS I4 FL4H
360417 -               081010................, ref SDS I3 SB8I
360418 -               081006................, ref SDS I1 3E4K
360419 -               081004................, ref SDS I0 Y17L
360420 -               081002................, ref SDS H9 Y17L
360421 -               080930................, ref SDS H8 Y17L
360422 -               080923................, ref SDS H6 K16F
360423 -               080915................, ref SDS H1 9W9I
360424 -               080810................, ref SDS F3 9W9I
360425 -               080803................, ref SDS E4 9W9I
360426 -               080726................, ref SDS E1 9W9I
360427 -               080721................, ref SDS D6 9W9I
360428 -               080713................, ref SDS C9 RM94
360429 -               080629................, ref SDS C2 6Q5J
360430 -               080628................, ref SDS C0 6Q5J
360431 -
360432 -
360433 -
360434 -
360435 -
3605 -

SUBJECTS
Default Null Subject Account for Blank Record

5103 -
510401 -  ..
510402 - Coagulation Control INR 2.5 Above Range Treating Pulmonary Embolism
510403 -
510404 - Follow up ref SDS N3 K66J, ref SDS M6 K66J.
510405 -
510406 - Labs today show INR 2.5 slightly above prescribed range of 2.0 to 3.0.
510407 - ref SDS 0 PU7Y
510408 -
510409 -     [On 090130 1722 medical team, including Gloria at Kaiser
510410 -     Cogaulation Control Clinic, was notified that INR 2.5 blood count
510411 -     returned to normal. ref SDS O0 AY6U
510413 -      ..
510414 -     [On 090207 1428 Millie received letter from Gloria asking
510415 -     for results of INR blood test since prior test at Kaiser on
510416 -     090122, and so indicates Kaiser has not read the mail from
510417 -     a week ago received on 090130 submitting updated INR 2.5
510418 -     resutls. ref SDS O1 4P8N
510419 -
510420 -
510421 -         ****************************************
510422 -         ****************************************
510424 -  ..
510425 - During the meeting with the medical team today, slight rise of INR to
510426 - 3.1 could be related to changes in the treatment plan.  On 081219
510427 - treatments with sunitinib and cyclophosphamide were suspended for 1
510428 - week until 081227, and treatment with Methotrexate was ended entirely.
510430 -  ..
510431 - Additionally, Millie recalled taking Coumadin treatment of order by 4
510432 - or 5 hours on 2 consecutive days within the past 3 or 4 days.  This
510433 - change in routine, which has since been corrected, might contribute to
510434 - increasing INR.
510436 -  ..
510437 - On 081126 Millie reported elevated INR 3.4 to Gloria at Kaiser
510438 - Coagulation Control Unit, ref SDS L6 J45H  Millie received a letter
510439 - from Gloria which adjusted the dose of Coumadin required to manage
510440 - Millie's chronic pulmonary embolism condition, now being taken with
510441 - sunitinib and cyclophosphamide taken to treat cancer. ref SDS L7 VQ8V
510442 -
510443 -
510444 -
510445 -
510446 -
510447 -
510448 -
510449 -
510450 -
5105 -