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: April 17, 2008 08:30 AM Thursday; Rod Welch

Millie 3rd treatment 2nd cycle cetuximab Carboplatin 4th relapse IBC.

1...Summary/Objective
...Taxotere Capecitabine Treatment IBC 2nd Relapse After Mastectomy
...Cetuxiab Alone Clinical Study
...Cetuxiab with Carboplatin Clinical Study 2nd Arm
2...Labs Blood Test
3...Neupogen Considered Increase Blood Counts for Next Treatment
4...Blood Counts Fall Below Safe Level Treatment Carboplatin Missed
5...Carboplatin Missed Treatment Blood Counts Fall Below Safe Level
6...Missed Carboplatin Treatment Blood Counts Fall Below Safe Level


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CONTACTS 

SUBJECTS
Meeting UCSF Infusion Clinic Agenda Cetuximab Carboplatin 2nd Arm Cl

1003 -
1003 -    ..
1004 - Summary/Objective
1005 -
100501 - Follow up ref SDS 96 0000. ref SDS 93 0000.
100502 -
100503 -
100504 -
100505 -
100506 -
100508 -  ..
1006 -
1007 -
1008 - Progress
1009 -
100901 - The first treatment on the clinical study began on 070201 with
100902 - cetuximab alone, ref SDS 12 G68I, and continued for 14 cycles each
100903 - comprisng 1 treatment every week on Thursday.  The second arm of the
100904 - clinical study adding Carboplatin chemotherapy to cetuximab was
100905 - ordered by the doctor on 080306. ref SDS 87 NW3N  The first treatment
100906 - with Carboplatin was delayed a week by the patient, ref SDS 87 M18J,
100907 - and so started on 080313. ref SDS 90 TZ8I
100909 -    ..
100910 -   Taxotere Capecitabine Treatment IBC 2nd Relapse After Mastectomy
100911 -
100912 -   Millie had left mastectomy on 051021.  Biopsy at that time reported
100913 -   no findings of cancer.  Approximately 8 months later on 060707 the
100914 -   doctor diagnosed IBC relapse and prescribed treatment. ref SDS 2
100915 -   PF3O
100916 -
100917 -    1.  Cycle 09 and 01 ................... 060721, ref SDS 3 407N
100918 -    2.  Cycle 10 and 02 ................... 060814, ref SDS 5 LY6O
100919 -    3.  Cycle 11 and 03 ................... 060908, ref SDS 5 407N
100920 -    4.  Cycle 12 and 04 ................... 060929, ref SDS 5 407N
100921 -    5.  Cycle 13 and 05 ................... 061020, ref SDS 6 407N
100922 -    6.  Cycle 14 and 06 ................... 061110, ref SDS 7 407N
100923 -    7.  Cycle 15 and 07 ................... 061201, ref SDS 8 407N
100925 -    ..
100926 -   Cetuxiab Alone Clinical Study
100927 -
100928 -   On 061208 the doctor diagnosed progression of disease.  This was
100929 -   Millie's 3rd relapse of IBC. ref SDS 9 025H  On 070105 the doctor
100930 -   prescribed treatment with a clinical trial for cetuximab and
100931 -   Carboplatin. ref SDS 10 PK68  Millie was randomized to start
100932 -   treatment with only cetuximab.  She began treatment with cetuximab
100933 -   alone on 070201...
100934 -
100935 -                   Total    Cetuximab
100936 -    8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 12 SG8I
100937 -    9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 13 SG8I
100938 -   10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 14 SG8I
100939 -   11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 15 SG8I
100940 -   12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 16 SG8I
100941 -   13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 18 7T3H
100942 -   14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 19 7T3H
100943 -   15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 20 7T3H
100944 -   16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 21 7T3H
100945 -   17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 22 7T3H
100946 -   18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 23 7T3H
100947 -   19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 24 7T3H
100948 -   20.  Cycle 04 and 11 and 01 13.......... 070426, ref SDS 25 7T3H
100949 -   21.  Cycle 04 and 11 and 02 14.......... 070503, ref SDS 26 7T3H
100950 -   22.  Cycle 04 and 11 and 03 15.......... 070510, ref SDS 27 7T3H
100951 -   23.  Cycle 04 and 11 and 04 16.......... 070517, ref SDS 28 7T3H
100952 -   24.  Cycle 05 and 12 and 01 17.......... 070524, ref SDS 29 7T3H
100953 -   25.  Cycle 05 and 12 and 02 18.......... 070531, ref SDS 30 7T3H
100954 -   26.  Cycle 05 and 12 and 03 19.......... 070607, ref SDS 31 7T3H
100955 -   27.  Cycle 05 and 12 and 04 20.......... 070614, ref SDS 32 0001
100956 -   28.  Cycle 06 and 13 and 01 21.......... 070621, ref SDS 33 0001
100957 -   29.  Cycle 06 and 13 and 02 22.......... 070628, ref SDS 34 0001
100958 -   30.  Cycle 06 and 13 and 03 23.......... 070705, ref SDS 35 0001
100959 -   31.  Cycle 06 and 13 and 04 24.......... 070712, ref SDS 36 0001
100960 -   32.  Cycle 07 and 14 and 01 25.......... 070719, ref SDS 37 0001
100961 -   33.  Cycle 07 and 14 and 02 26.......... 070726, ref SDS 38 0001
100962 -   34.  Cycle 07 and 14 and 03 27.......... 070802, ref SDS 39 0001
100963 -   35.  Cycle 07 and 14 and 04 28.......... 070809, ref SDS 40 0001
100964 -   36.  Cycle 08 and 15 and 01 29.......... 070816, ref SDS 41 0001
100965 -   37.  Cycle 08 and 15 and 02 30.......... 070823, ref SDS 42 0001
100966 -   38.  Cycle 08 and 15 and 03 31.......... 070830, ref SDS 42 0001
100967 -   39.  Cycle 08 and 15 and 04 32.......... 070906, ref SDS 43 0001
100968 -   40.  Cycle 09 and 16 and 01 33.......... 070920, ref SDS 44 0001
100969 -   41.  Cycle 09 and 16 and 02 34.......... 070927, ref SDS 45 0001
100970 -   42.  Cycle 09 and 16 and 03 35.......... 071004, ref SDS 46 0001
100971 -   43.  Cycle 09 and 16 and 04 36.......... 071011, ref SDS 48 0001
100972 -   44.  Cycle 10 and 17 and 01 37.......... 071018, ref SDS 49 0001
100973 -   45.  Cycle 10 and 17 and 02 38.......... 071025, ref SDS 50 0001
100974 -   46.  Cycle 10 and 17 and 03 39.......... 071101, ref SDS 51 0001
100975 -   47.  Cycle 10 and 17 and 04 40.......... 071108, ref SDS 52 0001
100976 -   48.  Cycle 11 and 18 and 01 41.......... 071115, ref SDS 53 0001
100977 -   49.  Cycle 11 and 18 and 02 42.......... 071122, ref SDS 55 0001
100978 -   50.  Cycle 11 and 18 and 03 43.......... 071129, ref SDS 56 0001
100979 -   51.  Cycle 11 and 18 and 04 44.......... 071206, ref SDS 57 0001
100980 -   52.  Cycle 12 and 19 and 01 45.......... 071213, ref SDS 59 0001
100981 -   53.  Cycle 12 and 19 and 02 46.......... 071220, ref SDS 63 0001
100982 -   54.  Cycle 12 and 19 and 03 47.......... 071227, ref SDS 64 0001
100983 -   55.  Cycle 12 and 19 and 04 48.......... 080103, ref SDS 65 0001
100984 -   56.  Cycle 13 and 20 and 01 49.......... 080110, ref SDS 67 0001
100985 -   57.  Cycle 13 and 20 and 02 50.......... 080117, ref SDS 69 0001
100986 -   58.  Cycle 13 and 20 and 03 51.......... 080124, ref SDS 70 0001
100987 -   59.  Cycle 13 and 20 and 04 52.......... 080131, ref SDS 72 0001
100988 -   60.  Cycle 14 and 21 and 01 53.......... 080207, ref SDS 76 0001
100989 -   61.  Cycle 14 and 21 and 02 54.......... 080214, ref SDS 77 0001
100990 -   62.  Cycle 14 and 21 and 03 55.......... 080221, ref SDS 82 0001
100991 -   63.  Cycle 14 and 21 and 04 56.......... 080228, ref SDS 85 0001
100992 -   64.  Cycle 15 and 22 and 01 57.......... 080306, ref SDS 88 TZ8I
100993 -
100995 -    ..
100996 -   Cetuxiab with Carboplatin Clinical Study 2nd Arm
100997 -
100998 -   On 080207 doctor reports IBC may be spreading. ref SDS 75 GH5H
100999 -   Emergency examination on 080219 diagnosed progression of disease,
101000 -   ref SDS 81 3J4I, citing CT test on 080212 reviewed on 080215 showing
101001 -   increased adenopathy. ref SDS 79 RX6J  Photographs show spread of
101002 -   IBC rash, On 080306 the doctor orders changing treatment by adding
101003 -   Carboplatin to cetuximab. ref SDS 87 NW3N  Patient decided to begin
101004 -   new treatment regimen the following week on 080313. ref SDS 87 M18J
101006 -                            ..
101007 -                           Cetuximab  Carbo  Date   Citation
101008 -   65.  Cycle 15 and 22 and 02 58 02  01... 080313, ref SDS 90 TZ8I
101009 -   66.  Cycle 15 and 22 and 03 59 03  01... 080320, ref SDS 91 TZ8I
101010 -   67.  Cycle 15 and 22 and 04 60 04  01... 080327, ref SDS 92 TZ8I
101011 -   68.  Cycle 16 and 23 and 01 61 05  02... 080403, ref SDS 93 TZ8I
101012 -   69.  Cycle 16 and 23 and 02 62 06  03... 080410, ref SDS 96 TZ8I
101013 -   70.  Cycle 16 and 23 and 03 63 07  03... 080417, ref SDS 0 TZ8I
101015 -  ..
101016 - Today is the 3rd treatment of the 2nd cycle with cetuximab and
101017 - Carboplatin together.  This is the 7th treatment overall with
101018 - cetuximab on the 2nd arm of the study, and the 63rd total treatments
101019 - with cetuximab in the the study.  Millie was scheduled today for what
101020 - would have been the 4th treatment overall and the 3rd treatment for
101021 - the 2nd cycle with Carboplatin of the 2nd arm for the clinical study.
101022 - Since labs show blood counts are too low today with NEUTS 1.34,
101023 - ref SDS 0 QY6H, Millie did not get treatment with Carboplatin today,
101024 - so the total number of treatments with Carboplatin remains at 3, as
101025 - shown in the table.
101026 -
101027 -
1011 -

SUBJECTS
Blood Tests Counts Low Immune System Not Safe Carboplatin Chemothera

2203 -
220401 -  ..
220402 - Labs Blood Test
220403 -
220404 - Follow up ref SDS 96 FW5N, ref SDS 93 FW5N.
220405 -
220406 - Adding Carboplatin to the treatment protocol now requires weekly blood
220407 - tests to determine if the immune system is strong enough for safe
220408 - chemotherapy treatment, reported on 070201, ref SDS 12 XR40, and
220409 - citing the clinical study protocol received from UCSF on 070116.
220410 - ref SDS 11 5U7Z
220412 -  ..
220413 - During treatment, Catherine submitted results of the test.
220414 -
220429 -     ..
220430 -    Log#:                   080417 08:15
220431 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
220432 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
220433 -     ..
220434 -    CBC with DIFF & PLT CT                                     CBCD
220435 -     ..
220436 -    WBC COUNT     L*        2.8    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
220437 -    RBC COUNT     L*        3.93   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
220438 -    HEMOGLOBIN             12.8    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
220439 -    HEMATOCRIT             37.4    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
220440 -    MCV                    95      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
220441 -    MCH                    32.5    pg           26  -   34     MCH
220442 -    MCHC                   34.2    g/dL         31  -   36     MCHC
220443 -    PLATELETS             268      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
220444 -    ..
220445 -     (NEUTS x 1000 = ANC for Kaiser)
220446 -    NEUTS         L*        0.95   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
220447 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
220449 -     ..
220450 -    LYMPHS                  1.38   x10E9/L     1.0  -  3.4     L-A   Lymphocytes       %        20  -  50
220451 -    MONOS         L*        0.16   x10E9/L     0.2  -  0.8     M-A   Monocyte          %         0  -  11
220452 -    EOS                     0.15   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
220453 -    BASOS                   0.07   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
220454 -    LUC/ATYP LYMPHS         0.07   x10E9/L       0  -  0.2     LALA  [No evident equivalent at Kaiser]
220456 -     ..
220457 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
220458 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
220459 -     ..
220460 -    ELECTROLYTE PANEL                                          LYTE
220461 -    SODIUM                136      mmol/L      134  -  143     NA    Sodium            mEq/L   137  -  145
220462 -    POTASSIUM               4.2    mmol/L      3.4  -  4.9     K     Potassium         mEq/L   3.5  -  5.3
220463 -    CHLORIDE              107      mmol/L       98  -  107     CL
220464 -    CARBON DIOX TOTAL      26      mmol/L       23  -  32      CO2
220465 -    ANION GAP               3                    3  -  14      ANGA
220467 -     ..
220468 -    MAGNESIUM      L        1.8    mg/dL       1.8  -  2.3     MG    Magnesium         mg/dL   1.6  -  2.3
220469 -
220470 -      Performed at Mt Zion Clinical Lab, 1600 Divisadero, San
220471 -      Francisco, CA 94115
220473 -     ..
220474 -    CREAT with eGFR
220475 -    CREATININE              0.50   mg/dL      0.42  - 1.06     CR    Creatinine        mg/dL   0.6  -  1.2
220476 -
220477 -      Note: Creatinine assay changed to IDMS standardization on
220478 -      February 4, 2008 causing decrease in results of approximately
220479 -      0.09 mg/dL
220481 -     ..
220482 -    eGFR if Caucasian     >60      mL/min                      GFRC
220483 -    eGFR if African Amer  >60      mL/min                      GFRA
220484 -
220485 -      eGFR corrected for 1.73 sq meters of body surface area
220486 -      Note:  eGFR is only an estimation. Please see online Lab Manual
220487 -      for potential limitations.
220488 -      Performed at Mt Zion Clin Lab, 1600 Divisadero, San Francisco,
220489 -      CA  94115
220490 -
220491 -
220492 -
220494 -  ..
220495 - Neupogen Considered Increase Blood Counts for Next Treatment
220496 - Blood Counts Fall Below Safe Level Treatment Carboplatin Missed
220497 - Carboplatin Missed Treatment Blood Counts Fall Below Safe Level
220498 - Missed Carboplatin Treatment Blood Counts Fall Below Safe Level
220499 -
220500 - Blood counts today NEUTS 0.95, ref SDS 0 QY6H, show dramatic decline
220501 - from NEUTS 6.85 reported for the test last week on 080410. ref SDS 96
220502 - QY6H  Continues erratic patient history for NEUTS blood counts that
220503 - signal when the immune system is strong enough for safe chemotherapy
220504 - treatments with Carboplatin, discussed previously in the record on
220505 - 080403. ref SDS 93 PU6K
220507 -  ..
220508 - Concern anticipating Problems maintaining blood counts for safe
220509 - treatment with chemotherapy was reported in the letter to the medical
220510 - team on 080307. ref SDS 89 HS6R
220512 -  ..
220513 - Catherine called Brigid and left a message that blood counts are very
220514 - low today, just a week after being very high.  The medical team did
220515 - not call with any instructions by the time treatment ended about 1200.
220517 -  ..
220518 - As a result, Millie did not get Carboplatin treatment based on
220519 - Chemotherapy Orders for the 3rd cycle received on 080403. ref SDS 93
220520 - M86N
220521 -
220522 -        [...in another record Millie notifies Kaiser blood counts
220523 -        lowest ever, missed treatment, ref SDS 98 P45J; went to Kaiser
220524 -        Pharmacy and got refill on Neupogen, ref SDS 98 4W7S; requests
220525 -        instructions on number of Neupogen treatments needed.
220526 -        ref SDS 98 4W7X
220528 -         ..
220529 -        [On 080418 Brigid says Neupogen treatment not needed this
220530 -        week, because not Carboplatin chemothearpy next week for
220531 -        4th treatment in the cycle; discusses new treatment plan
220532 -        lowering dose of Carboplatin to achieve consistent
220533 -        treatments. ref SDS 90 MR3L
220535 -         ..
220536 -        [On 080904 case study neutropenia Millie's patient history.
220537 -        ref SDS 90 8O7I
220538 -
220539 -
220540 -
220541 -
220542 -
2206 -