CONTACTS 

SUBJECTS
Cetuximab Carboplatin Clinical Study 2nd Arm 6th Cycle 3rd Treatment

1003 -
1003 -    ..
1004 - Summary/Objective
1005 -
100501 - Follow up ref SDS E4 0000. ref SDS D9 0000.
100502 -
100503 -
100504 -
100505 -
100506 -
100507 -
100509 -  ..
1006 -
1007 -
1008 - Progress
1009 -
100901 - Background on Millie's treatment in the clinical study is reported on
100902 - 080508. ref SDS 97 TZ8I
100904 -    ..
100905 -   Taxotere Capecitabine 2nd Relapse IBC Treatment After Mastectomy
100906 -
100907 -   Follow up ref SDS E4 X33O, ref SDS D9 X33O.
100908 -
100909 -   Millie had left mastectomy on 051021.  Biopsy at that time reported
100910 -   no findings of cancer.  Approximately 8 months later on 060707 the
100911 -   doctor diagnosed IBC relapse and prescribed treatment. ref SDS 5
100912 -   PF3O
100913 -
100914 -    1.  Cycle 09 and 01 ................... 060721, ref SDS 6 407N
100915 -    2.  Cycle 10 and 02 ................... 060814, ref SDS 8 LY6O
100916 -    3.  Cycle 11 and 03 ................... 060908, ref SDS 8 407N
100917 -    4.  Cycle 12 and 04 ................... 060929, ref SDS 8 407N
100918 -    5.  Cycle 13 and 05 ................... 061020, ref SDS 9 407N
100919 -    6.  Cycle 14 and 06 ................... 061110, ref SDS 10 407N
100920 -    7.  Cycle 15 and 07 ................... 061201, ref SDS 11 407N
100922 -    ..
100923 -   Cetuxiab Alone Clinical Study
100924 -
100925 -   Follow up ref SDS E4 356I, ref SDS D9 356I.
100926 -
100927 -                   Total    Cetuximab
100928 -    8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 13 SG8I
100929 -    9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 14 SG8I
100930 -   10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 15 SG8I
100931 -   11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 16 SG8I
100932 -   12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 17 SG8I
100933 -   13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 19 7T3H
100934 -   14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 20 7T3H
100935 -   15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 21 7T3H
100936 -   16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 22 7T3H
100937 -   17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 23 7T3H
100938 -   18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 24 7T3H
100939 -   19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 25 7T3H
100940 -   20.  Cycle 04 and 11 and 01 13.......... 070426, ref SDS 26 7T3H
100941 -   21.  Cycle 04 and 11 and 02 14.......... 070503, ref SDS 27 7T3H
100942 -   22.  Cycle 04 and 11 and 03 15.......... 070510, ref SDS 28 7T3H
100943 -   23.  Cycle 04 and 11 and 04 16.......... 070517, ref SDS 29 7T3H
100944 -   24.  Cycle 05 and 12 and 01 17.......... 070524, ref SDS 30 7T3H
100945 -   25.  Cycle 05 and 12 and 02 18.......... 070531, ref SDS 31 7T3H
100946 -   26.  Cycle 05 and 12 and 03 19.......... 070607, ref SDS 32 7T3H
100947 -   27.  Cycle 05 and 12 and 04 20.......... 070614, ref SDS 33 0001
100948 -   28.  Cycle 06 and 13 and 01 21.......... 070621, ref SDS 34 0001
100949 -   29.  Cycle 06 and 13 and 02 22.......... 070628, ref SDS 35 0001
100950 -   30.  Cycle 06 and 13 and 03 23.......... 070705, ref SDS 36 0001
100951 -   31.  Cycle 06 and 13 and 04 24.......... 070712, ref SDS 36 0001
100952 -   32.  Cycle 07 and 14 and 01 25.......... 070719, ref SDS 37 0001
100953 -   33.  Cycle 07 and 14 and 02 26.......... 070726, ref SDS 35 0001
100954 -   34.  Cycle 07 and 14 and 03 27.......... 070802, ref SDS 36 0001
100955 -   35.  Cycle 07 and 14 and 04 28.......... 070809, ref SDS 38 0001
100956 -   36.  Cycle 08 and 15 and 01 29.......... 070816, ref SDS 39 0001
100957 -   37.  Cycle 08 and 15 and 02 30.......... 070823, ref SDS 40 0001
100958 -   38.  Cycle 08 and 15 and 03 31.......... 070830, ref SDS 40 0001
100959 -   39.  Cycle 08 and 15 and 04 32.......... 070906, ref SDS 41 0001
100960 -   40.  Cycle 09 and 16 and 01 33.......... 070920, ref SDS 42 0001
100961 -   41.  Cycle 09 and 16 and 02 34.......... 070927, ref SDS 43 0001
100962 -   42.  Cycle 09 and 16 and 03 35.......... 071004, ref SDS 44 0001
100963 -   43.  Cycle 09 and 16 and 04 36.......... 071011, ref SDS 45 0001
100964 -   44.  Cycle 10 and 17 and 01 37.......... 071018, ref SDS 46 0001
100965 -   45.  Cycle 10 and 17 and 02 38.......... 071025, ref SDS 47 0001
100966 -   46.  Cycle 10 and 17 and 03 39.......... 071101, ref SDS 33 0001
100967 -   47.  Cycle 10 and 17 and 04 40.......... 071108, ref SDS 48 0001
100968 -   48.  Cycle 11 and 18 and 01 41.......... 071115, ref SDS 49 0001
100969 -   49.  Cycle 11 and 18 and 02 42.......... 071122, ref SDS 35 0001
100970 -   50.  Cycle 11 and 18 and 03 43.......... 071129, ref SDS 52 0001
100971 -   51.  Cycle 11 and 18 and 04 44.......... 071206, ref SDS 53 0001
100972 -   52.  Cycle 12 and 19 and 01 45.......... 071213, ref SDS 56 0001
100973 -   53.  Cycle 12 and 19 and 02 46.......... 071220, ref SDS 59 0001
100974 -   54.  Cycle 12 and 19 and 03 47.......... 071227, ref SDS 60 0001
100975 -   55.  Cycle 12 and 19 and 04 48.......... 080103, ref SDS 61 0001
100976 -   56.  Cycle 13 and 20 and 01 49.......... 080110, ref SDS 64 0001
100977 -   57.  Cycle 13 and 20 and 02 50.......... 080117, ref SDS 65 0001
100978 -   58.  Cycle 13 and 20 and 03 51.......... 080124, ref SDS 66 0001
100979 -   59.  Cycle 13 and 20 and 04 52.......... 080131, ref SDS 68 0001
100980 -   60.  Cycle 14 and 21 and 01 53.......... 080207, ref SDS 72 0001
100981 -   61.  Cycle 14 and 21 and 02 54.......... 080214, ref SDS 73 0001
100982 -   62.  Cycle 14 and 21 and 03 55.......... 080221, ref SDS 36 0001
100983 -   63.  Cycle 14 and 21 and 04 56.......... 080228, ref SDS 78 0001
100984 -   64.  Cycle 15 and 22 and 01 57 01  00... 080306, ref SDS 81 TZ8I
100986 -    ..
100987 -   Cetuxiab with Carboplatin Clinical Study 2nd Arm
100988 -
100989 -   Follow up ref SDS E4 5B6J, ref SDS D9 5B6J.
100990 -
100991 -   On 080207 doctor reports IBC may be spreading. ref SDS 71 GH5H
100992 -   Follow up examination on 080219 Doctor Rugo diagnosed progression of
100993 -   disease. ref SDS 91 3J4I  Photographs show spread of IBC rash,
100994 -
100995 -             2nd
100996 -             Arm              Cetuximab Carboplatin
100997 -   65.  Cycle 01 15 and 22 and 02 58 02  01... 080313, ref SDS 82 TZ8I
100998 -   66.  Cycle 01 15 and 22 and 03 59 03  01... 080320, ref SDS 83 TZ8I
100999 -   67.  Cycle 01 15 and 22 and 04 60 04  01... 080327, ref SDS 84 TZ8I
101000 -   68.  Cycle 02 16 and 23 and 01 61 05  02... 080403, ref SDS 85 TZ8I
101001 -   69.  Cycle 02 16 and 23 and 02 62 06  03... 080410, ref SDS 88 TZ8I
101002 -   70.  Cycle 02 16 and 23 and 03 63 07  03... 080417, ref SDS 90 TZ8I
101003 -   71.  Cycle 02 16 and 23 and 04 64 08  03... 080424, ref SDS 92 TZ8I
101004 -   72.  Cycle 03 17 and 24 and 01 65 09  04... 080501, ref SDS 95 5B6J
101005 -   73.  Cycle 03 17 and 24 and 02 66 10  05... 080508, ref SDS 97 5B6J
101006 -   74.  Cycle 03 17 and 24 and 03 67 11  05... 080515, ref SDS 98 5B6J
101007 -   75.  Cycle 03 17 and 24 and 04 68 12  05... 080522, ref SDS 99 5B6J
101008 -   76.  Cycle 04 18 and 25 and 01 69 13  06... 080529, ref SDS A2 5B6J
101009 -   77.  Cycle 04 18 and 25 and 02 70 14  07... 080605, ref SDS A3 5B6J
101010 -   78.  Cycle 04 18 and 25 and 03 71 15  08... 080612, ref SDS A6 5B6J
101011 -   79.  Cycle 04 18 and 25 and 04 72 16  08... 080619, ref SDS A9 5B6J
101012 -   80.  Cycle 05 19 and 26 and 01 73 17  09... 080626, ref SDS B4 5B6J
101013 -   81.  Cycle 05 19 and 26 and 02 74 18  10... 080703, ref SDS B9 5B6J
101014 -   82.  Cycle 05 19 and 26 and 03 75 19  11... 080710, ref SDS C2 5B6J
101015 -   83.  Cycle 05 19 and 26 and 04 76 20  11... 080717, ref SDS C8 5B6J
101016 -   84.  Cycle 06 20 and 27 and 01 77 21  12... 080724, ref SDS D5 5B6J
101017 -   85.  Cycle 06 20 and 27 and 02 78 22  13... 080731, ref SDS D9 5B6J
101018 -   86.  Cycle 06 20 and 27 and 03 79 23  14... 080807, ref SDS E4 5B6J
101019 -   87.  Cycle 06 20 and 27 and 04 80 24  14... 080814, ref SDS 0 5B6J
101021 -  ..
101022 - Today is the 4th treatment of the 6th cycle with cetuximab and
101023 - Carboplatin together.  This is the 24th treatment overall with
101024 - cetuximab on the 2nd arm of the clinical study, but is only the 14th
101025 - treatment with Carboplatin due to low blood counts.
101027 -  ..
101028 - Diane is the nurse today.  Catherine is still on vacation until
101029 - 080821.
101030 -
101031 -
101032 -
101033 -
1011 -

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

1803 -
1804 - 0800
180501 -  ..
180502 - Labs Blood Test
180503 -
180504 - Follow up ref SDS E4 FW5N, ref SDS D9 FW5N.
180505 -
180506 - Adding Carboplatin to the treatment protocol now requires weekly blood
180507 - tests to determine if the immune system is strong enough for safe
180508 - chemotherapy treatment, reported on 070201, ref SDS 13 XR40, and citing
180509 - the clinical study protocol received from UCSF on 070116. ref SDS 12
180510 - 5U7Z
180512 -  ..
180513 - During treatment, Diane submitted results of the test.
180514 -
180529 -     ..
180530 -    Log#:                   080814 08:15
180531 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
180532 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
180533 -     ..
180534 -    CBC with DIFF & PLT CT                                     CBCD
180535 -     ..
180536 -    WBC COUNT               3.7    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
180537 -    RBC COUNT      L        3.64   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
180538 -    HEMOGLOBIN             12.5    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
180539 -    HEMATOCRIT             36.0    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
180540 -    MCV                    99      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
180541 -    MCH            H       34.4    pg           26  -   34     MCH
180542 -    MCHC                   34.8    g/dL         31  -   36     MCHC
180543 -    PLATELETS             228      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
180544 -
180545 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
180546 -        Francisco, CA  94115
180547 -    ..
180548 -     (NEUTS x 1000 = ANC for Kaiser)
180549 -    NEUTS         L         1.37   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
180550 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
180552 -     ..
180553 -    LYMPHS                  1.71   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
180554 -    MONOS                   0.38   x10E9/L     0.1  -  0.6     M-A   Monocyte          %         0  -  11
180555 -    EOS                     0.16   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
180556 -    BASOS                   0.07   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
180558 -     ..
180559 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
180560 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
180561 -    ELECTROLYTE PANEL                                          LYTE
180562 -    SODIUM                136      mmol/L      134  -  143     NA    Sodium            mEq/L   137  -  145
180563 -    POTASSIUM               4.3    mmol/L      3.4  -  4.9     K     Potassium         mEq/L   3.5  -  5.3
180564 -    CHLORIDE              103      mmol/L       98  -  107     CL
180565 -    CARBON DIOX TOTAL L    23      mmol/L       23  -  32      CO2
180566 -    ANION GAP              10                    3  -  14      ANGA
180567 -     ..
180568 -    CALCIUM          L      8.4    mg/dL       8.7  - 10.1     CA    Calcium           mg/dL   8.4  - 10.2
180569 -     ..
180570 -    MAGNESIUM        L      1.7    mg/dL       1.8  -  2.3     MG    Magnesium         mg/dL   1.6  -  2.3
180571 -
180572 -
180573 -
180574 -
180575 -
1806 -

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

2703 -
270401 -  ..
270402 - NEUTS Decrease Neupogen No Treatments on Bye Week 4th Chemo in Cycle
270403 - Side Effects Neupogen Treatments Continue Mild Tolerance Acceptable
270404 -
270405 - Follow up ref SDS E4 PU6K, ref SDS D9 PU6K.
270406 -
270407 - Blood counts decrease this week, shown by the Lab report today with
270408 - NEUTS 1.37, ref SDS 0 QY6H, compared with NEUTS 2.41 last week on
270409 - 080807, ref SDS E4 QY6H  This is below UCSF minimum of 1.8 for Millie
270410 - to safely get chemotherapy treatment.  Since today is the bye week in
270411 - the cycle for Carboplatin, low blood counts do not prevent getting
270412 - treatment with cetuximab today.
270414 -  ..
270415 - At the time Millie left the hospital today, Diane had not received
270416 - instructions from Brigid on Neupogen.  This suggests the Chemotherapy
270417 - Orders on 080724 that indicate Neupogen treatment is not required this
270418 - week are in effect.
270420 -  ..
270421 - Decrease in blood counts today demonstrates a roller coaster above and
270422 - below specified target from week to week, even while getting a steady
270423 - dose of Neupogen in recent months.
270425 -  ..
270426 - Labs showing NEUTS 1.37 today may be close enough so that not getting
270427 - Carboplatin today enables skipping Neupogen this week, as well.  If
270428 - so, Kaiser has to be notifed to cancel treatments scheduled in the
270429 - Infusion Clinic on Friday and Saturday, per instructions from Bonnie
270430 - last Saturday on 080809. ref SDS E7 WJ4O
270432 -               ..
270433 -              Date       Neupogen  NEUTS   Cycl Trmnt
270434 -
270435 -               080814........0..... 1.37.....6...4... ref SDS 0 QY6H
270436 -               080807........2..... 2.41.....6...3... ref SDS E4 QY6H
270437 -               080731........2..... 1.92.....6...2... ref SDS D9 QY6H
270438 -               080724........2..... 2.32.....6...1... ref SDS D5 QY6H
270439 -          *    080717........1..... 2.47.....5...4... ref SDS C8 QY6H
270440 -               080710........2..... 5.12.....5...3... ref SDS C2 QY6H
270441 -               080703........2..... 2.90.....5...2... ref SDS B9 QY6H
270442 -               080626........2..... 1.80.....5...1... ref SDS B4 QY6H
270443 -               080619........1..... 0.74.....4...4... ref SDS A9 QY6H
270444 -               080612........2..... 3.77.....4...3... ref SDS A6 QY6H
270445 -
270446 -                   On 080609 Kaiser orders 2 Neupogen treatments per
270447 -                   week in Infusion Clinic, ref SDS A5 IL6I, for UCSF
270448 -                   prescription in Chemo Orders on 080529, ref SDS A5
270449 -                   L16I, which were received on 080605. ref SDS A3 JN38
270451 -                ..
270452 -               080605........2..... 1.55.....4...2... ref SDS A3 QY6H
270453 -               080529........1..... 2.26.....4...1... ref SDS A2 QY6H
270454 -               080522........0..... 0.96.....3...4... ref SDS 99 QY6H
270455 -               080515........0..... 1.21.....3...3... ref SDS 98 QY6H
270456 -               080508........1..... 5.41.....3...2... ref SDS 97 QY6H
270457 -               080501........1..... 1.34.....3...1... ref SDS 95 QY6H
270458 -               080424........0..... 1.34.....2...4... ref SDS 92 QY6H
270459 -               080417........0..... 0.95.....2...3... ref SDS 90 QY6H
270460 -               080410........0..... 6.85.....2...2... ref SDS 88 QY6H
270461 -               080403........1..... 1.34.....2...1... ref SDS 85 QY6H
270462 -               080327........0..... 2.30.....1...4... ref SDS 84 QY6H
270463 -               080320........0..... 1.28.....1...3... ref SDS 83 QY6H
270464 -               080313........0..... 2.05.....1...2... ref SDS 82 QY6H
270465 -               080306........0..... 1.75.....1...1... ref SDS 81 QY6H
270467 -  ..
270468 - Side effects of Neupogen may be lessening, reported on...
270469 -
270470 -               080810................, ref SDS E8 9W9I
270471 -               080803................, ref SDS E0 9W9I
270472 -               080726................, ref SDS D7 9W9I
270473 -               080721................, ref SDS D2 9W9I
270474 -               080713................, ref SDS C5 RM94
270475 -               080629................, ref SDS B8 6Q5J
270476 -               080628................, ref SDS B6 6Q5J
270477 -
270478 - ...suggesting increased ability to tolerate 2 Neupogen treatments per
270479 - week.
270480 -
270481 -
270482 -
270483 -
270484 -
270485 -
270486 -
2705 -