CONTACTS 

SUBJECTS
Cetuximab 12th Cycle 3rd Treatment 18th Total Treatment Chemotherapy

0403 -
0403 -    ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS 95 0000. ref SDS 94 0000.
040502 -
040503 -
040504 -
040505 -
040506 -
040507 -
040509 -  ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - Background on Millie's treatment in the clinical study is reported on
040902 - 080508. ref SDS 95 TZ8I
040904 -    ..
040905 -   Taxotere Capecitabine 2nd Relapse IBC Treatment After Mastectomy
040906 -
040907 -   Follow up ref SDS 95 XX3O, ref SDS 94 X33O.
040908 -
040909 -   Millie had left mastectomy on 051021.  Biopsy at that time reported
040910 -   no findings of cancer.  Approximately 8 months later on 060707 the
040911 -   doctor diagnosed IBC relapse and prescribed treatment. ref SDS 2
040912 -   PF3O
040913 -
040914 -    1.  Cycle 09 and 01 ................... 060721, ref SDS 3 407N
040915 -    2.  Cycle 10 and 02 ................... 060814, ref SDS 5 LY6O
040916 -    3.  Cycle 11 and 03 ................... 060908, ref SDS 5 407N
040917 -    4.  Cycle 12 and 04 ................... 060929, ref SDS 5 407N
040918 -    5.  Cycle 13 and 05 ................... 061020, ref SDS 6 407N
040919 -    6.  Cycle 14 and 06 ................... 061110, ref SDS 7 407N
040920 -    7.  Cycle 15 and 07 ................... 061201, ref SDS 8 407N
040922 -    ..
040923 -   Cetuxiab Alone Clinical Study
040924 -
040925 -   Follow up ref SDS 95 356I, ref SDS 94 356I.
040926 -
040927 -                   Total    Cetuximab
040928 -    8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 10 SG8I
040929 -    9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 11 SG8I
040930 -   10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 12 SG8I
040931 -   11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 13 SG8I
040932 -   12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 14 SG8I
040933 -   13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 16 7T3H
040934 -   14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 17 7T3H
040935 -   15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 18 7T3H
040936 -   16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 19 7T3H
040937 -   17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 20 7T3H
040938 -   18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 21 7T3H
040939 -   19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 22 7T3H
040940 -   20.  Cycle 04 and 11 and 01 13.......... 070426, ref SDS 23 7T3H
040941 -   21.  Cycle 04 and 11 and 02 14.......... 070503, ref SDS 24 7T3H
040942 -   22.  Cycle 04 and 11 and 03 15.......... 070510, ref SDS 25 7T3H
040943 -   23.  Cycle 04 and 11 and 04 16.......... 070517, ref SDS 26 7T3H
040944 -   24.  Cycle 05 and 12 and 01 17.......... 070524, ref SDS 27 7T3H
040945 -   25.  Cycle 05 and 12 and 02 18.......... 070531, ref SDS 28 7T3H
040946 -   26.  Cycle 05 and 12 and 03 19.......... 070607, ref SDS 29 7T3H
040947 -   27.  Cycle 05 and 12 and 04 20.......... 070614, ref SDS 30 0001
040948 -   28.  Cycle 06 and 13 and 01 21.......... 070621, ref SDS 31 0001
040949 -   29.  Cycle 06 and 13 and 02 22.......... 070628, ref SDS 32 0001
040950 -   30.  Cycle 06 and 13 and 03 23.......... 070705, ref SDS 33 0001
040951 -   31.  Cycle 06 and 13 and 04 24.......... 070712, ref SDS 34 0001
040952 -   32.  Cycle 07 and 14 and 01 25.......... 070719, ref SDS 35 0001
040953 -   33.  Cycle 07 and 14 and 02 26.......... 070726, ref SDS 36 0001
040954 -   34.  Cycle 07 and 14 and 03 27.......... 070802, ref SDS 37 0001
040955 -   35.  Cycle 07 and 14 and 04 28.......... 070809, ref SDS 38 0001
040956 -   36.  Cycle 08 and 15 and 01 29.......... 070816, ref SDS 39 0001
040957 -   37.  Cycle 08 and 15 and 02 30.......... 070823, ref SDS 40 0001
040958 -   38.  Cycle 08 and 15 and 03 31.......... 070830, ref SDS 40 0001
040959 -   39.  Cycle 08 and 15 and 04 32.......... 070906, ref SDS 41 0001
040960 -   40.  Cycle 09 and 16 and 01 33.......... 070920, ref SDS 42 0001
040961 -   41.  Cycle 09 and 16 and 02 34.......... 070927, ref SDS 43 0001
040962 -   42.  Cycle 09 and 16 and 03 35.......... 071004, ref SDS 44 0001
040963 -   43.  Cycle 09 and 16 and 04 36.......... 071011, ref SDS 45 0001
040964 -   44.  Cycle 10 and 17 and 01 37.......... 071018, ref SDS 46 0001
040965 -   45.  Cycle 10 and 17 and 02 38.......... 071025, ref SDS 47 0001
040966 -   46.  Cycle 10 and 17 and 03 39.......... 071101, ref SDS 48 0001
040967 -   47.  Cycle 10 and 17 and 04 40.......... 071108, ref SDS 49 0001
040968 -   48.  Cycle 11 and 18 and 01 41.......... 071115, ref SDS 50 0001
040969 -   49.  Cycle 11 and 18 and 02 42.......... 071122, ref SDS 36 0001
040970 -   50.  Cycle 11 and 18 and 03 43.......... 071129, ref SDS 52 0001
040971 -   51.  Cycle 11 and 18 and 04 44.......... 071206, ref SDS 53 0001
040972 -   52.  Cycle 12 and 19 and 01 45.......... 071213, ref SDS 56 0001
040973 -   53.  Cycle 12 and 19 and 02 46.......... 071220, ref SDS 59 0001
040974 -   54.  Cycle 12 and 19 and 03 47.......... 071227, ref SDS 60 0001
040975 -   55.  Cycle 12 and 19 and 04 48.......... 080103, ref SDS 61 0001
040976 -   56.  Cycle 13 and 20 and 01 49.......... 080110, ref SDS 64 0001
040977 -   57.  Cycle 13 and 20 and 02 50.......... 080117, ref SDS 65 0001
040978 -   58.  Cycle 13 and 20 and 03 51.......... 080124, ref SDS 66 0001
040979 -   59.  Cycle 13 and 20 and 04 52.......... 080131, ref SDS 68 0001
040980 -   60.  Cycle 14 and 21 and 01 53.......... 080207, ref SDS 72 0001
040981 -   61.  Cycle 14 and 21 and 02 54.......... 080214, ref SDS 73 0001
040982 -   62.  Cycle 14 and 21 and 03 55.......... 080221, ref SDS 37 0001
040983 -   63.  Cycle 14 and 21 and 04 56.......... 080228, ref SDS 79 0001
040984 -   64.  Cycle 15 and 22 and 01 57 01  00... 080306, ref SDS 82 TZ8I
040985 -
040987 -    ..
040988 -   Cetuxiab with Carboplatin Clinical Study 2nd Arm
040989 -
040990 -   Follow up ref SDS 95 5B6J, ref SDS 94 5B6J.
040991 -
040992 -   On 080207 doctor reports IBC may be spreading. ref SDS 71 GH5H
040993 -   Follow up examination on 080219 Doctor Rugo diagnosed progression of
040994 -   disease. ref SDS 76 3J4I  Photographs show spread of IBC rash,
040995 -
040996 -             2nd
040997 -             Arm              Cetuximab Carboplatin
040998 -   65.  Cycle 01 15 and 22 and 02 58 02  01... 080313, ref SDS 83 TZ8I
040999 -   66.  Cycle 01 15 and 22 and 03 59 03  01... 080320, ref SDS 84 TZ8I
041000 -   67.  Cycle 01 15 and 22 and 04 60 04  01... 080327, ref SDS 85 TZ8I
041001 -   68.  Cycle 02 16 and 23 and 01 61 05  02... 080403, ref SDS 86 TZ8I
041002 -   69.  Cycle 02 16 and 23 and 02 62 06  03... 080410, ref SDS 89 TZ8I
041003 -   70.  Cycle 02 16 and 23 and 03 63 07  03... 080417, ref SDS 91 TZ8I
041004 -   71.  Cycle 02 16 and 23 and 04 64 08  03... 080424, ref SDS 93 TZ8I
041005 -   72.  Cycle 03 17 and 24 and 01 65 09  04... 080501, ref SDS 94 5B6J
041006 -   73.  Cycle 03 17 and 24 and 02 66 10  05... 080508, ref SDS 95 5B6J
041007 -   74.  Cycle 03 17 and 24 and 03 67 11  05... 080515, ref SDS 0 5B6J
041009 -  ..
041010 - Today is the 3rd treatment of the 3rd cycle with cetuximab and
041011 - Carboplatin together.  This is the 11th treatment overall with
041012 - cetuximab on the 2nd arm of the clinical study, but is only the 5th
041013 - treatment with Carboplatin due to low blood counts, since Millie again
041014 - today did not get Carboplatin because NEUTS are way too low, per
041015 - below. ref SDS 0 PU6K
041016 -
041017 -
041018 -
041019 -
0411 -

SUBJECTS
Default Null Subject Account for Blank Record

0503 -
050401 -  ..
050402 - Labs Blood Test
050403 -
050404 - Follow up ref SDS 95 FW5N, ref SDS 94 FW5N.
050405 -
050406 - Adding Carboplatin to the treatment protocol now requires weekly blood
050407 - tests to determine if the immune system is strong enough for safe
050408 - chemotherapy treatment, reported on 070201, ref SDS 10 XR40, and citing
050409 - the clinical study protocol received from UCSF on 070116. ref SDS 9
050410 - 5U7Z
050412 -  ..
050413 - During treatment, Catherine submitted results of the test.
050414 -
050429 -     ..
050430 -    Log#:                   080403 08:00
050431 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
050432 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
050433 -     ..
050434 -    CBC with DIFF & PLT CT                                     CBCD
050435 -     ..
050436 -    WBC COUNT      L        3.3    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
050437 -    RBC COUNT               4.09   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
050438 -    HEMOGLOBIN             13.1    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
050439 -    HEMATOCRIT             38.7    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
050440 -    MCV                    94      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
050441 -    MCH                    32.1    pg           26  -   34     MCH
050442 -    MCHC                   34.0    g/dL         31  -   36     MCHC
050443 -    PLATELETS             248      x10E9/L     140  -  450     PLT   Plt x10-3        K/uL     140  -  400
050444 -
050445 -        Performed at Mt Zion Clinic Lab, 1600 Divisadero, San
050446 -        Francisco, CA  94115
050447 -    ..
050448 -     (NEUTS x 1000 = ANC for Kaiser)
050449 -    NEUTS         L         1.21   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
050450 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
050452 -     ..
050453 -    LYMPHS                  1.63   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
050454 -    MONOS                   0.23   x10E9/L     0.1  -  0.6     M-A   Monocyte          %         0  -  11
050455 -    EOS                     0.15   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
050456 -    BASOS                   0.06   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
050458 -  ..
050459 - Blood counts fell today with NEUTS 1.21, ref SDS 0 QY6H, compared with
050460 - NEUTS 5.41 last week on 080508, ref SDS 85 QY6H, continues erratic
050461 - history with no evident pattern associated with significantly
050462 - increased exercise.
050464 -  ..
050465 - Megan visited with Millie in the Infusion Clinic.
050467 -  ..
050468 - She initially explained that the doctor has proposed to the Clinical
050469 - Study sponsors deferring treatment today, and Millie come in next
050470 - Tuesday to get Carboplatin.  Millie would then come back on Thursday
050471 - to get cetuximab alone, which is normally the bye week Carboplatin in
050472 - the 4-week cycle of cetuximab.  Megan will check further whether
050473 - Millie should take a Neupogen this week, say tomorrow or Saturday.
050475 -  ..
050476 - The doctor evidently was notified by the Clinical Study sponsors
050477 - recommending that Millie skip Carboplatin entirely this week, as well
050478 - as next week, which is the normal bye week.  This aligns with prior
050479 - practice when Millie has skipped treatments with low blood counts,
050480 - reported on 080320, ref SDS 84 TZ8I, and again on 080417. ref SDS 91
050481 - 0001
050483 -  ..
050484 - Megan advised that Millie will not need to take Neupogen this week
050485 - either, since she is not getting Carboplatin.  May have to start
050486 - taking Neupogen twice per week to maintain blood counts for weekly
050487 - Carboplatin 3 weeks in a row required by the clinical trial protocol.
050488 - So far, Millie has been able to get treatments with Carboplating 2
050489 - weeks a row, even with 1 treatment of Neupogen.
050491 -  ..
050492 - Millie asked for the Chemotherapy Orders issued on 080501 starting the
050493 - cycle, which were not received from UCSF at that time.  The nurse made
050494 - a copy from the medical chart, and gave Millie 2 Chemotherapy Orders,
050495 - which are entered in the record on 080501 showing control of the work.
050496 - ref SDS 94 4E9N
050497 -
050498 -
050499 -
050500 -
050501 -
050502 -
050503 -
050504 -
050505 -
050506 -
0506 -