CONTACTS 

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

1003 -
1003 -    ..
1004 - Summary/Objective
1005 -
100501 - Follow up ref SDS 51 0000. ref SDS 50 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 4 G68I, and continued for 14 cycles.
100904 -  ..
100905 - Today is the 1st treatment of the 2nd cycle with cetuximab and
100906 - Carboplatin together.  This is the 5th treatment overall with
100907 - cetuximab and the 2nd treatment overall with Carboplatin starting the
100908 - 2nd cycle of the 2nd arm for the clinical study.
100909 -
100910 -
100911 -
100912 -
1010 -

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

1903 -
1904 - 0805
190501 -  ..
190502 - Labs Blood Test
190503 -
190504 - Follow up ref SDS 51 FW5N, ref SDS 50 FW5N.
190505 -
190506 - Adding Carboplatin to the treatment protocol now requires weekly blood
190507 - tests to determine if the immune system is strong enough for safe
190508 - chemotherapy treatment, reported on 070201, ref SDS 4 XR40, and citing
190509 - the clinical study protocol received from UCSF on 070116. ref SDS 3
190510 - 5U7Z
190512 -  ..
190513 - Millie came to the 5th floor Infusion Clinic this morning for a blood
190514 - draw requested in her letter to UCSF yesterday on 080402. ref SDS 52
190515 - Q24T
190517 -  ..
190518 - She then went to the 2nd floor for the meeting with the Medical Team
190519 - to evaluate the blood test for Millie to safely get treatment for
190520 - cancer today with chemotherapy (Carboplatin).
190521 -
190523 -  ..
1906 -
1907 -
1908 - 1047
1909 -
190901 - During treatment, Catherine submitted results of the test.
190902 -
190917 -     ..
190918 -    Log#:                   080403 08:25
190919 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
190920 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
190921 -     ..
190922 -    CBC with DIFF & PLT CT                                     CBCD
190923 -     ..
190924 -    WBC COUNT               3.6    x10E9/L     3.4  -   10     WBC   WBC x10-3        K/uL     3.4  -  10.0
190925 -    RBC COUNT               4.24   x10E12/L      4  -   5.2    RBC   RBC x10-6        M/uL    3.60  -  5.70
190926 -    HEMOGLOBIN             13.5    g/dL         12  -   15.5   HGB   Hemoglobin       g/dL    11.5  -  15.0
190927 -    HEMATOCRIT             39.3    PERCENT      36  -   46     HCT   Hematocrit       %       34.0  -  46.0
190928 -    MCV                    93      fL           80  -   100    MCV   MCV              fL      80.0  -  100.0
190929 -    MCH                    31.9    pg           26  -   34     MCH
190930 -    MCHC                   34.4    g/dL         31  -   36     MCHC
190931 -    PLATELETS             175      x10E9/L     140  -   450    PLT   Plt x10-3        K/uL     140  -  400
190932 -    ..
190933 -       (posted 080410, ref SDS 57 WE4N)
190934 -    CA 15-3      H*        66      U/mL             <  33     CA153  CA 15-3                        <  39
190935 -
190936 -         Note new reference range [<33 changed from <31] and change in
190937 -         methodology effective March 1, 2008.  Performed using the
190938 -         Siemens Centaur Chemiluminesence method.  CA 15-3 result using
190939 -         the Roche Elecsys assay is 75 U/mL.  Ref range <31 U/mL.  This
190940 -         rebaseline value provided at no additional charge.
190942 -          ..
190943 -         This new note updates explanation of tests prior to 080301,
190944 -         e.g., on 080207. ref SDS 39 A16M
190945 -    ..
190946 -     (NEUTS x 1000 = ANC for Kaiser)
190947 -    NEUTS         L         1.34   x10E9/L     1.8  -  6.8     N-A   ANC                      1500
190948 -    Neutrophils    Not Reported                                      Neutrophils       %        50  -  70
190950 -     ..
190951 -    LYMPHS                  1.50   x10E9/L     0.9  -  2.9     L-A   Lymphocytes       %        20  -  50
190952 -    MONOS                   0.44   x10E9/L     0.1  -  0.6     M-A   Monocyte          %         0  -  11
190953 -    EOS                     0.27   x10E9/L       0  -  0.4     E-A   Esoinophils       %         1  -  5
190954 -    BASOS                   0.08   x10E9/L       0  -  0.1     B-A   Basophil          %         0  -  2
190955 -                                                                                                 0  -  5
190956 -     ..
190957 -    <----------------------- U C S F -----------------------> <-------------  Kaiser -------------->
190958 -    Type                 Results   Units        Normal        ACRO   Type            Units        Normal
190959 -    PT            H        25.7    s          12.0  -  14.1    PT    PT, patient       sec     8.9  -  11.1
190960 -    INL NRM Ratio H         2.3                0.9  -  1.1     INR   INR                       2.0  -  3.0
190962 -     ..
190963 -    ELECTROLYTE PANEL                                          LYTE
190964 -    SODIUM                138      mmol/L      134  -  143     NA    Sodium            mEq/L   137  -  145
190965 -    POTASSIUM               4.0    mmol/L      3.4  -  4.9     K     Potassium         mEq/L   3.5  -  5.3
190966 -    CHLORIDE              103      mmol/L       98  -  107     CL
190967 -    CARBON DIOX TOTAL      24      mmol/L       23  -  32      CO2
190968 -    ANION GAP              11                    3  -  14      ANGA
190969 -     ..
190970 -    UREA NITROGEN          11      mg/dL         8  -  23      BUN   BUN               mg/dL     7  -  17
190971 -    GlUCOSE               133      mg/dL        70  -  199     GLU   Glucose           mg/dL     ?  -   ?
190972 -    AST                    40      U/L          16  -  41      AST   AST (SGOT)        U/L      14  -  36
190973 -    ALT                    20      U/L          11  -  54      ALT   ALT (SGPT)        U/L      11  -  66
190974 -    BILIRUBIN, TOTAL        0.8    mg/dL       0.3  - 1.3      BILT  Bili Total        mg/dL   0.2  - 1.3
190975 -    ALKALINE PHOSPHATASE   53      U/L          29  - 111      ALKP  Alkaline Ph       U/L      38  - 126
190976 -    PROTEIN, TOTAL          6.2    g/dL        5.8  - 8.0      TP    Protine Total     g/dL    6.3  - 8.2
190977 -    ALBUMIN                 3.9    g/dL        3.4  - 4.7      ALB   Albumin           g/dL    3.4  - 4.8
190978 -    CALCIUM                 8.9    mg/dL       8.7  - 10.1     CA    Calcium           mg/dL   8.4  - 10.2
190979 -     ..
190980 -    MAGNESIUM      L        1.5    mg/dL       1.8  -  2.3     MG    Magnesium         mg/dL   1.6  -  2.3
190981 -
190982 -        Note:  there was no report for Magnesium in the test today,
190983 -        however the next day on 080404 Brigid called and advised that
190984 -        Jackie added Magnesium to the test specification and this was
190985 -        performed on the blood draw today, with the result that the
190986 -        complete test results include Magnesium. ref SDS 55 O059
190987 -
190988 -            [On 080404 Brigid reported results for Magnesium 1.5, which
190989 -            is below the target range, ref SDS 55 OP4O, and the doctor
190990 -            ordered treatment to increase blood counts with "Magnesium
190991 -            Replacement." ref SDS 55 OP6U
190993 -             ..
190994 -            [On 080405 Pharmacist discloses Kaiser does not sell
190995 -            products for Magnesium Replacement; customers must buy
190996 -            Calcium and Magnesium dietary supplement tablets taken 3
190997 -            times a day for unknown number of days. ref SDS 56 J23S
190999 -     ..
191000 -    CREAT with eGFR
191001 -    CREATININE              0.51   mg/dL      0.42  - 1.06     CR    Creatinine        mg/dL   0.6  -  1.2
191002 -
191003 -      Note: Creatinine assay changed to IDMS standardization on
191004 -      February 4, 2008 causing decrease in results of approximately
191005 -      0.09 mg/dL
191007 -     ..
191008 -    eGFR if Caucasian     >60      mL/min                      GFRC
191009 -    eGFR if African Amer  >60      mL/min                      GFRA
191010 -
191011 -      eGFR corrected for 1.73 sq meters of body surface area
191012 -      Note:  eGFR is only an estimation. Please see online Lab Manual
191013 -      for potential limitations.
191014 -      Performed at Mt Zion Clin Lab, 1600 Divisadero, San Francisco,
191015 -      CA  94115
191017 -  ..
191018 - Blood counts fell significantly today, e.g., NEUTS 1.34, ref SDS 0
191019 - QY6H, compared with NEUTS 2.30 last week on 080327, ref SDS 51 QY6H,
191020 - presents erratic history with no evident pattern associated with
191021 - treatments nor exercise.  This conflicts with planning last week on
191022 - 080327 to rely on exercise for maintaining blood counts, ref SDS 51
191023 - PV3N, and so implies Neupogen may be the only solution, as prescribed
191024 - by the doctor during examination this morning.
191025 -
191026 -        [On 080904 case study neutropenia Millie's patient history.
191027 -        ref SDS 59 8O7I
191028 -
191029 -
191030 -
191031 -
191032 -
1911 -

SUBJECTS
INR 2.3 Coagulation Control Coumadin Treatment Pulmonary Embolism PT
Blood Tests Labs Infusion Clinic Evaluate Safe Chemotherapy 1st Trea

3104 -
310501 -  ..
310502 - Coagulation Control INR 2.3 Normal Stable PT 25.7 High
310503 -
310504 - Follow up ref SDS 51 SE6N, ref SDS 50 SE6N.
310505 -
310506 - INR 2.3 was normal in the blood test today. ref SDS 0 PU7Y
310507 -
310508 -
310509 -
310510 -
3106 -

SUBJECTS
Absolute Neutrophils Count ANC 1340 Below 1500 Safe Level UCSF Requi

4403 -
440401 -  ..
440402 - Carboplatin Treatment Safe Immune System Blood Counts NEUTS 1.34
440403 - NEUTS 1.34 Blood Counts Immune System Safe Carboplatin Treatment
440404 - Neupogen Prescribed Increase NEUTS Blood Counts for Treatment Next Week
440405 -
440406 - Follow up ref SDS 51 PU6K.
440407 -
440408 - Despite NEUTS 1.34 today, ref SDS 0 QY6H, falling from 2.30 last week
440409 - on 080327, ref SDS 51 PU6K, earlier this morning, the doctor approved
440410 - treatment with Carboplatin chemotherapy today, because NEUTS 1.34 is
440411 - close enough with Millie's evident good health and rising energy,
440412 - together with prescribing 1 treatment of Neupogen this week that will
440413 - increase blood counts further for treatment next week on 080410.  The
440414 - Neupogen treatment was prescribed by the doctor in another record
440415 - today. ref SDS 53 XV4G
440417 -  ..
440418 - Approval of treatment is noted in the Chemotherapy Orders received
440419 - today, and shown below. ref SDS 0 PU4T
440420 -
440421 -
440422 -
4405 -

SUBJECTS
Magnesium Blood Test Missing from Labs Medical Mistakes Conflicts Ch

5403 -
540401 -  ..
540402 - Magnesium No Report for Blood Test Today
540403 -
540404 - Follow up ref SDS 32 4F9G, ref SDS 29 JH6F.
540405 -
540406 - Previously, on 080110 Magnesium was not shown in the blood test
540407 - report. ref SDS 29 JH6F  An updated report for the test on 080110 was
540408 - received on 080117 and it showed that Magnesium was in fact tested on
540409 - 080110, and was at the low end of the target range, indicating
540410 - response to treatment prescribed for the prior period on 071213.
540411 - ref SDS 32 4F9G
540413 -  ..
540414 - Magnesium 1.8 was within the prescribed range and at the low end for
540415 - the test on 080207. ref SDS 39 PN8H
540417 -  ..
540418 - Magnesium 2.1 was within the prescribed and at the high end for the
540419 - test on 080313. ref SDS 48 BN9I
540421 -  ..
540422 - There was no report on Magnesium for the blood test this morning; the
540423 - next day on 080404, Brigid called and reported Magnesium was tested,
540424 - and is low, per above. ref SDS 0 CP6J
540425 -
540426 -            [On 080404 Brigid reported results for Magnesium 1.5, which
540427 -            is below the target range, ref SDS 55 OP4O, and the doctor
540428 -            ordered treatment to increase blood counts with "Magnesium
540429 -            Replacement." ref SDS 55 OP6U
540431 -             ..
540432 -            [On 080405 Pharmacist discloses Kaiser does not sell
540433 -            products for Magnesium Replacement; customers must buy
540434 -            Calcium and Magnesium dietary supplement tablets taken 3
540435 -            times a day for unknown number of days. ref SDS 56 J23S
540437 -             ..
540438 -            [On 080410 blood test shows Magnesium 1.9 which is within
540439 -            the target range, and indicates effective treatment ordered
540440 -            by UCSF on 080404. ref SDS 57 RW6F
540441 -
540442 -
540443 -
540444 -
540445 -
540446 -
5405 -

SUBJECTS
Chemotherapy Orders 2nd Cycle 1st Treatment Clinical Study Drug Tria

6003 -
600401 -  ..
600402 - Chemotherapy Orders...
600403 -
600404 - Follow up ref SDS 49 4E9N.
600405 -
600406 - Millie received a new chemotherapy order today by Doctor Rugo, and
600407 - prepared by Brigid during the meeting.  This order prescribing
600408 - Carboplatin chemotherapy treatment added to Cetuximab alone prescribed
600409 - initially on 070201. ref SDS 4 4N5M
600410 -
600411 -         [On 080501 UCSF changed the practice of Millie delivering the
600412 -         Clinical Study blood vials and Chemotherapy Orders from the
600413 -         meeting on the 2nd floor to the Infusion Clinic on the 5th
600414 -         floor. ref SDS 58 4E9N
600416 -  ..
600417 - Only major difference between the orders today and for last month on
600418 - 080306 (reported on 080313) is Carboplatin was increased today from
600419 - 230 mg on 080313, to 250 mg today. ref SDS 0 4F56
600420 -
600421 -
600427 -    Auth#                                     Stor BCC LOC
600428 -    Visit:  13986278             DOS 20080403
600430 -     ..
600431 -    Date:  20080403
600433 -     ..
600434 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
600435 -    in combination with Carboplatin in ER-negative, PR-negative,
600436 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers.
600438 -     ..
600439 -    Arm:  2 - Cetuximab + Carboplatin
600441 -     ..
600442 -    Dates to be given: 20080403
600444 -     ..
600445 -    Allergies:  NKDA
600447 -     ..
600448 -    Height:  62 inches
600450 -     ..
600451 -    Weight:  139 pounds
600453 -     ..
600454 -    Diagnosis:  Metastatic breast cancer (IBC)
600456 -     ..
600457 -    ICD-9 codes: 174.9/198.2/174.?? (this runs off the page)
600458 -                       skin
600460 -  ..
600461 - This seems different from Chemotherapy Order for Carboplatin on 080313
600462 - that shows 174.4. ref SDS 49 IJ37
600463 -
600464 -            [On 080501 codes assigned to Chemotherapy Order for the
600465 -            next cycle are much different from codes assigned today.
600466 -            ref SDS 58 PVSS
600468 -     ..
600469 -    Cycle:  2
600471 -     ..
600472 -    Days:  1, 8, 15  (arm 2)
600473 -
600475 -     ..
600476 -    Antimetics:
600477 -
600478 -    Follow up ref SDS 49 2N43.
600479 -
600480 -    x  Dexamethasone    10 mg   IV     (Decadron)
600481 -    x  Ondansetron  8 mg   IV          (Zofran)
600482 -
600484 -     ..
600485 -    Chemotherapy (plan to treat weekly for 3 out of 4 weeks).
600486 -
600487 -    Follow up ref SDS 49 2N4N.
600488 -
600489 -    May administer Carboplatin if vital signs are unremarkable one
600490 -    hour after cetuximab infusion..
600491 -
600492 -    ** Please note start and stop times **
600494 -     ..
600495 -    Carboplatin (commercial supply) AUC 2 = 250 mg
600497 -  ..
600498 - Chemo orders for last cycle dated 080306 and begun on 080313 seems to
600499 - show Carboplatin 230 mg. ref SDS 49 4F56
600500 -
600501 -          [On 080501 UCSF Chemotherapy Orders for 3rd cycle seems to
600502 -          reduce dose by 50% from 250 mg down to 175 mg. ref SDS 58
600503 -          PVUY
600505 -  ..
600506 - Chemotherapy Orders continue...
600507 -
600508 -    IV over 30 minutes weekly x 3 doses followed by 1 week rest.
600510 -  ..
600511 - [hand writting...]
600512 -
600513 -               Carbo dose to remain the same unless CR >= 1.3
600515 -  ..
600516 - [...where CR = "Creatinine"]
600517 -
600518 -            Carboplatin dose in mg = (desired AUC)(GFR+25)
600519 -
600520 -        GFR (estimated) =
600521 -
600522 -               (140-age in years)(weight in kg)(for females x 0.85)
600523 -               ----------------------------------------------------
600524 -                         (Cr in mg/dL)(72)
600526 -  ..
600527 - There is handwriting on the formula that seems to associate "age in
600528 - years = 68; and weight in kg = 63; and CR in mg/dL = 0.51
600530 -  ..
600531 - Millie's age = 72.... so, 104 - 72 = 68
600532 - Millie's weight in pounds = 140 = 63.5 kg.
600533 - CR in mg/dL = 0.51............................... ref SDS 0 8U4N
600535 -  ..
600536 - Thus, looks like handwritten values are correct.
600538 -  ..
600539 - If this calculates to 250 mg treatment with Carboplatin, they why was
600540 - the treatment in the order issued on 080306 with the first treatment
600541 - on 080313 230 mg? ref SDS 49 4F56
600543 -  ..
600544 - Only variable seems to be weight, 139 on 080313, and 140 today.  Hard
600545 - to believe that less than 1% increase change in weight would require
600546 - 10% increase in dose, i.e., from 230 to 250 mg.
600548 -  ..
600549 - Suppose the patient lost 10 pounds, would dose drop to zero?
600551 -  ..
600552 - Chemotherapy Orders continues...
600554 -     ..
600555 -    Laboratory work:
600556 -
600557 -    Follow up ref SDS 49 2N6N.
600558 -
600559 -    x  CBC with differential and platelets
600560 -    x  Creatinine, magnesium every 4 weeks
600561 -    x  BUN, AST, Alk phos, Alt, Total bilirubin, eletrolytes every 8 weeks
600562 -
600563 -            [On 080404 Magnesium was omitted from labs for 080403, and
600564 -            corrected the next day on 080404. ref SDS 49 OA8K
600566 -  ..
600567 - On 070201 chemotherapy order for cetuximab alone appears identical to
600568 - requirements for laboratory blood tests. ref SDS 3 5594
600570 -  ..
600571 - Chemotherapy Orders continues...
600572 -
600573 -    If ANC >= 1.5 x 1000/L, platelets >= 75 x 1000/L give 100% of dose
600575 -     ..
600576 -    If ANC <  1.5 x 1000/L, platelets <  75 x 1000/L....
600577 -
600581 -        ..
600582 -       See cetuximab orders. [received on 070201. ref SDS 3 II5G]
600584 -  ..
600585 - For some reason this instruction is not selected, which conflicts with
600586 - the record on 080313 for the initial order. ref SDS 49 4F92
600588 -  ..
600589 - Chemotherapy Orders continue...
600591 -  ..
600592 - Handwriting says at this point near bottom of the form...
600593 -
600594 -           OK.. ANC = 1.34; Day 2 Neupogen 480 mg @ Kaiser
600596 -  ..
600597 - Chemotherapy Orders continue...
600599 -     ..
600600 -    x  Physician has discussed risks/benefits of chemotherapy with the
600601 -       patient.  Consent, form obtained.
600602 -
600603 -       x  Yes  O2 [oxygyn] by nasal cannula at 2 liters/min prn for chest pain or SOB
600605 -           ..
600606 -       x  Yes  Diphenhydramine 50 mg IV prn x 1 unticaria pruntis, SOB
600607 -               (this is Benadryl)
600609 -        ..
600610 -       x  Yes  Hydrocrotisone 100 mg IV prn x 1 unticaria pruntis, SOB
600612 -        ..
600613 -       x  Yes  Aubterol inhaler 2 - 4 puffs prn SOB or chest tightness
600615 -        ..
600616 -       x  Yes  Epnephnna nhaler 2 - 4 puffs prn SOB or chest tightness
600618 -        ..
600619 -       Physician Signature
600620 -
600623 -                Date:  080306
600625 -        ..
600626 -       Nurse Signature:
600627 -
600630 -                Date:  080313
600632 -  ..
600633 - No nurses signature is shown in the copy received from UCSF; may have
600634 - been entered and filed in UCSF records later.
600635 -
600636 -
600637 -
600638 -
600639 -
600640 -
600641 -
600642 -
600643 -
600644 -
600645 -
600646 -
6007 -