CONTACTS 

SUBJECTS
UCSF Investigating Millie Qualify IBC Treatment Clinical Study Drug

1403 -
1403 -    ..
1404 - Summary/Objective
1405 -
140501 - Follow up ref SDS 70 0000. ref SDS 69 0000.
140502 -
140503 - UCSF reported progress today scheduling Millie to meet with Doctor
140504 - Rugo, and begin treatment.  Jackie called to coordinate Millie getting
140505 - treatment for IBC with Cetuximab Carboplatin clinical drug trial
140506 - study, ref SDS 0 NK8F, which UCSF and Kaiser indicate is the best
140507 - course for Millie. ref SDS 0 RB37  UCSF is working to qualify Millie
140508 - on measurable disease, and on the number of previous treatments.
140509 - ref SDS 0 JS5G  Discussed timeliness to start treatment for
140510 - progressing disease; Jackie planned to expedite UCSF processing and
140511 - submit a letter for Millie to review consent forms to enroll in the
140512 - treatment study. ref SDS 0 HR6N  Later in the afternoon, Millie
140513 - received a letter from Jackie submitting consent form, and scheduling
140514 - treatment to start OA 070124, next week. ref SDS 0 RT7K  This early
140515 - start of treatment would allow Millie to avoid having another PET/CT
140516 - scan test to set a baseline for the trial study. ref SDS 0 4296
140517 - Millie can rely on UCSF and Kaiser proposing treatment that is
140518 - targeted to breast cancer. ref SDS 0 I65I  Review of consent forms
140519 - presents a few questions which UCSF can address in time to avoid
140520 - delaying treatment. ref SDS 0 I662
140522 -             ..
140523 -            [On 070117 Millie's letter to UCSF presents questions on
140524 -            consent forms for participating in the study. ref SDS 72
140525 -            HT3Q
140526 -
140527 -
140528 -
140529 -
140531 -  ..
1406 -
1407 -
1408 - Progress
1409 -
140901 - Cetuximab Carboplatin Clinical Drug Trial UCSF Initial Discussion
140902 -
140903 - Follow up ref SDS 70 1G3K, ref SDS 69 087J.
140904 -
140905 - On 070110 Millie received a letter from the primary care physician
140906 - submitting Kaiser's letter on 070108 to expedite review by UCSF for
140907 - Millie to start treatment in a clinical drug trial. ref SDS 69 NN6I
140909 -  ..
140910 - Millie reported to Kaiser on 070113 that UCSF had not made contact.
140911 - ref SDS 70 II4R
140913 -  ..
140914 - Today, Jackie called about scheduling Millie for a meeting with Doctor
140915 - Rugo at UCSF, as planned in the doctor's letter to Kaiser received on
140916 - 070101. ref SDS 65 519M
140918 -  ..
140919 - Jackie is the clincial trial coordinator for the UCSF Cancer Center.
140921 -  ..
140922 - She indicated today that there are two issues being reviewed by UCSF
140923 - medical team to qualify Millie for drug trials...
140924 -
140925 -        1.  Measurable disease.
140926 -
140927 -            Patient history shows measurable disease for IBC does not
140928 -            register routinely with image testing, discussed recently
140929 -            in a letter to Kaiser on 061228. ref SDS 63 T66Y  Kaiser
140930 -            did not present IBC spreading from left to right breast to
140931 -            UCSF, noted in a letter from UCSF to Kaiser on 061230.
140932 -            ref SDS 64 PO3V  This was cited again in the letter from
140933 -            UCSF received on 070101. ref SDS 65 E23S
140935 -             ..
140936 -            Jackie indicated UCSF may be able to meet requirements for
140937 -            measurable disease by making physical measurements of
140938 -            infection shown by inflammation on the skin, which has
140939 -            progressed significantly, most recently from the left to
140940 -            the right breast, reported by the primary care physician
140941 -            during the examination on 061208. ref SDS 56 025H
140943 -             ..
140944 -            Reviewed patient history considering photograhic records to
140945 -            assess measurable disease, listed in the record on 070101.
140946 -            ref SDS 65 4Q6K
140947 -
140948 -               [On 070130 UCSF planning to take photographs of IBC rash
140949 -               to measure progress of disease required for clinical
140950 -               study drug trial. ref SDS 77 M661
140952 -                ..
140953 -               [On 070201 Jackie took pictures of infected IBC tissue
140954 -               with a tape measure held in various angles to assess
140955 -               measurable disease. ref SDS 79 HQ3J
140957 -             ..
140958 -        2.  AC treatments split between 2002 and 2005; concern this
140959 -            constitutes 2 treatments would disqualify Millie for
140960 -            clinical study.
140962 -             ..
140963 -            Patient history shows treatment in 2005 was to complete
140964 -            initial treatment in 2002 which was halted before being
140965 -            completed, reported on 041230. ref SDS 19 XQ84
140967 -  ..
140968 - Discussed timeliness.
140970 -  ..
140971 - Millie's last treatment was on 061201, ref SDS 53 0001, and her
140972 - disease is advancing shown by examination on 070105.  Jackie said that
140973 - Doctor Rugo is expediting Millie's case to start treatment as quickly
140974 - as possible.
140975 -
140976 -     [...below Jackie's letter today indicates Millie can meet with
140977 -     Doctor Rugo in time to start treatment next week OA 060124, and
140978 -     will not require getting another PET/CT test. ref SDS 0 P69J
140980 -  ..
140981 - Jackie requested Millie's email address.
140983 -  ..
140984 - Jackie plans to submit a letter to Millie Thursday or Friday to
140985 - schedule a meeting with Doctor Rugo on planning treatment regimen.
140987 -  ..
140988 - Discussed clinical study drug trials that can help Millie.
140990 -  ..
140991 - UCSF's letter to Kaiser on 061229, and received in the record on
140992 - 061230 indicated the first effort is to qualify Millie for treatment
140993 - with Cetuximab Carboplatin clinical drug trial. ref SDS 64 PN5X
140995 -  ..
140996 - Doctor Benz 2nd opinion received through Kaiser on 060929 indicated
140997 - Millie could qualify for at least 2 trials...
140998 -
140999 -      1.  Phase II evaluation of cetuximab alone versus cetuximab plus
141000 -          carboplatin, and
141002 -           ..
141003 -      2.  Phase I evaluation of Abraxane in combination with lapatinib.
141004 -
141005 - ...supported by UCSF. ref SDS 45 UI9K
141007 -  ..
141008 - Reviewed work on 061230 indicating Lapatinib is targeted to treat IBC.
141009 - ref SDS 64 I43O
141011 -  ..
141012 - Subsequently, on 070105 the primary care physician at Kaiser indicated
141013 - that cetuximab is targeted to treat breast cancer, rather than generic
141014 - chemotherapy, like Navelbine and Gemzar.
141015 -
141016 -
141017 -
1411 -
141101 -
1412 -

SUBJECTS
Consent Forms Received Cetuximab Carboplatin Triple Negative Study C

1603 -
1604 - 1952
160501 -  ..
160502 - UCSF Expedites Starting Treatment Before 070124
160503 - Consent Forms Received Clinical Drug Trial UCSF Cetuximab Carboplatin
160504 - Cetuximab Carboplatin Triple Negative Study Clinical Drug Trial UCSF
160505 -
160506 - Millie received ref DRT 1 0001 from Jackie at UCSF with a copy to
160507 - Doctor Rugo, and confirming discussions today, per above, ref SDS 0
160508 - NK8F, and saying...
160509 -
160510 -     [On 070130 followed up. ref SDS 77 TQ6L
160512 -  ..
160513 - This is great work, expediting the schedule discussed earlier today
160514 - when Jackie planned to submit this letter in a few days. ref SDS 0
160515 - HR6N
160517 -  ..
160518 - UCSF's letter to Millie says...
160519 -
160520 -    1.  Below is the consent form for the triple negative study
160521 -        (cetuximab with or without carboplatin). ref SDS 0 0Q7I  Your
160522 -        recent PET/CT scan would allow you to be eligible for the study
160523 -        until next Wednesday, Jan 24, pending a confirmation of
160524 -        eligibility from the sponsor. ref DRT 1 0001
160526 -         ..
160527 -    2.  Dr Rugo would be able to see you before then if you are
160528 -        interested in the study.  You would be able to start at a later
160529 -        date, but the scans may need to be repeated. ref DRT 1 BG6K
160531 -         ..
160532 -    3.  Please look over the consent form and contact me with any
160533 -        questions. ref DRT 1 726I
160535 -  ..
160536 - During the meeting at Kaiser on 070105 the primary care physician said
160537 - that Cetuximab Carboplatin Triple Negative Study Clinical Drug Trial
160538 - recommended by Doctor Benz at UCSF in a 2nd opinion received on
160539 - 060929, ref SDS 45 UI9K, and noted in correspondence by Doctor Rugo
160540 - received on 061230, ref SDS 64 PN5X, offers a better course of
160541 - treatment than anything Kaiser has available at the present time,
160542 - including Navelbine, or Gemzar, ref SDS 67 PK7L, also, mentioned in
160543 - the 2nd opinion by Doctor Benz.  Reasoning confirmed in a letter to
160544 - Kaiser on 070109 seems to rest on Cetuximab being targeted to treat
160545 - breast cancer, rather than a generic chemotherapy that affects the
160546 - entire body. ref SDS 68 V84T
160547 -
160549 -  ..
160550 - Triple Negative Clinical Study Targets Millie's Status
160551 - Cetuximab Carboplatin Clinical Study Targets Triple Negative Status
160552 -
160553 - The consent form says in part...
160554 -
160555 -            LCCC 0403:  Phase II Trial Of Cetuximab Alone And In
160556 -            Combination With Carboplatin In ER-Negative, PR-Negative,
160557 -            Her-2 Nonoverexpressing Metastatic Breast Cancers,
160558 -            ref DRT 1 A29F
160560 -  ..
160561 - Millie was diagnosed triple negative on 020321. ref SDS 2 LA7O
160563 -  ..
160564 - On 041117 Doctor Benz 2nd opinion reports patient not candidate for
160565 - Herceptin because HER-2/neu negativity. ref SDS 16 YN4I  On 050907
160566 - Kaiser internal referral doctor recommends retesting for status change
160567 - that could have a huge impact on treatment options. ref SDS 26 AE6P
160568 -
160569 -                [On 060201 Jackie explains meaning of "triple negative"
160570 -                status that qualified Millie for participation in the
160571 -                study. ref SDS 79 ZV7N
160573 -  ..
160574 - Millie's status as triple negative now qualifies for additional
160575 - treatment.
160577 -  ..
160578 - Triple negative requirement limits number of patients who qualify for
160579 - the study, per below. ref SDS 0 1H3O
160580 -
160581 -
160582 -
1606 -

SUBJECTS
Patients Randomized for Cetuximab Also Get Carboplatin If Disease Pr

2003 -
200401 -  ..
200402 - Patients Randomized for Cetuximab Can Also Get Carboplatin If Needed
200403 -
200404 - A key representation in the study consent form says in part...
200406 -             ..
200407 -            In this study, cetuximab will be used either alone or in
200408 -            combination with a chemotherapy drug called carboplatin.
200409 -            Carboplatin is an accepted drug for use in metastatic
200410 -            breast cancer.  Researchers think that adding a
200411 -            chemotherapy drug to cetuximab may increase the effect;
200412 -            however, we don't yet know if this does happen.   Subjects
200413 -            who receive cetuximab alone will be able to receive
200414 -            cetuximab and carboplatin if their disease gets worse on
200415 -            cetuximab alone. ref DRT 1 00EO
200416 -
200417 -                [On 070130 Doctor Rugo confirmed that if Millie is
200418 -                treated initially only with cetuximab, she can be
200419 -                switched to get both drugs, if disease progresses.
200420 -                ref SDS 77 NI6K
200422 -                 ..
200423 -                [On 070201 Millie was randomized to get only Cetuximab.
200424 -                ref SDS 79 XR3M
200426 -                 ..
200427 -                [On 070202 primary care physician notices new rash on
200428 -                upper left arm, which is a symptom of cellulitis,
200429 -                ref SDS 80 JP6F but could be progression of IBC
200430 -                disease. ref SDS 80 JP6L
200432 -                 ..
200433 -                [On 070222 examination at UCSF indicates new rash
200434 -                likely progression of IBC. ref SDS 81 B64F
200436 -                 ..
200437 -                [On 070301 IBC progression to left arm, evident rise CA
200438 -                15-3 cancer marker presents prognosis of failed
200439 -                response to treatment, requiring increasing
200440 -                prescription from cetuximab alone to add carboplatin.
200441 -                ref SDS 82 OL5M
200443 -                 ..
200444 -                [On 070419 UCSF reports clinical study no longer
200445 -                accepting patients for treatment with cetuximab alone,
200446 -                because this treatment has not proven effective.
200447 -                ref SDS 85 Q65N
200449 -                 ..
200450 -                [On 070524 CA 15-3 37 cancer marker rises 30% signals
200451 -                effectiveness of treatment with cetuximab alone may be
200452 -                ending; since IBC continues to subside, and CT tests
200453 -                shown no progression of disease, decided to continue
200454 -                with cetuximab alone now. ref SDS 86 357I
200456 -                 ..
200457 -                [On 070607 Millie must sign a waiver to continue
200458 -                treatment with cetuximab alone, as a result of the
200459 -                change in the clinical study protocol. ref SDS 87 AT8L
200460 -
200461 -
200462 -
2005 -

SUBJECTS
Cetuximab Carboplatin 100 Patients Clinical Study 20 Patients at UCS

3103 -
310401 -             ..
310402 -            100 Patients Clinical Study 20 at UCSF Currently 6
310403 -
310404 -            Approximately 100 patients from around the country are
310405 -            expected to participate in the study, including
310406 -            approximately 20 subjects from UCSF. ref DRT 1 1H3O
310407 -
310408 -                [On 070201 UCSF apparently currently has only 6
310409 -                patients in the study, because very few patients meet
310410 -                protocol requirements, ref SDS 79 X44L, for triple
310411 -                negative, per above. ref SDS 0 0Q7I
310413 -  ..
310414 - This seems fairly small sample, and limited experience to evaluate
310415 - effectivenss and reaction to side effects across a wide range of
310416 - genetic variance.
310418 -  ..
310419 - Since this is a phase II study, ref DRT 1 A29F, phase I results
310420 - increase confidence in understanding expections on effectiveness and
310421 - reaction to side effects.
310423 -  ..
310424 - Study language continues...
310425 -
310426 -            Scans to measure your tumor - CT scan, x-ray, bone scan,
310427 -            MRI or PET scan.  These tests may not need to be repeated
310428 -            if you have had them within 4 weeks prior to beginning
310429 -            study drug. ref DRT 1 YA6H
310431 -             ..
310432 -            ...tumor tissue from your original breast cancer surgery or
310433 -            biopsy will be obtained from your hospital and used to
310434 -            confirm the "triple negative" status and look at proteins
310435 -            that effect EGFR. ref DRT 1 PF6N
310437 -             ..
310438 -            The cetuximab is given by vein once weekly.  The
310439 -            carboplatin is given by vein once weekly for 3 of 4 weeks.
310440 -            The study treatment is stopped if you have serious side
310441 -            effects or the tumor grows despite treatment.  If the
310442 -            treatment is working, you may continue on it indefinitely.
310443 -            ref DRT 1 5U7S
310444 -
310445 -               [On 070130 Doctor Rugo explained protocol requirements.
310446 -               ref SDS 77 IJ6L
310448 -                ..
310449 -               [On 071030 Paula asks how long the clinical trial for
310450 -               Millie lasts for resolving payment dispute between
310451 -               Kaiser and UCSF. ref SDS 88 UB5S
310453 -             ..
310454 -            Weekly blood counts will be done.  You will also have blood
310455 -            taken (about 3 tablespoons) after the first 1-2 weeks of
310456 -            new treatment, every 4 weeks during treatment ,and if your
310457 -            disease gets worse to look for circulating tumor cells.  If
310458 -            you have a high level of circulating tumor cells, you may
310459 -            be asked to give another blood sample (about 1 tablespoon)
310460 -            at your next visit.  Your tumor will be measured by x-rays
310461 -            every 8 weeks. ref DRT 1 5U7Z
310463 -             ..
310464 -            The examinations and x-rays are considered a normal part of
310465 -            cancer care and are not investigational.  Some of the blood
310466 -            tests, like blood counts and chemistries, are a normal part
310467 -            of cancer care.  Others are investigational, such as
310468 -            genetic tests to see whether your body handles these drugs
310469 -            differently from other people, and tests to examine tumor
310470 -            cells that might be circulating in the bloodstream.
310471 -            ref DRT 1 5U9U
310473 -  ..
310474 - Blood tests for normal cancer care evaluate the immune system for
310475 - patients to safely receive chemotherapy treatments, explained by the
310476 - primary care physician at Kaiser on 030606. ref SDS 6 JP7G  Case study
310477 - on 060810 show Millie's fitness permitted getting treatment when blood
310478 - counts are below the normal level for safe chemotherapy. ref SDS 42
310479 - HV45
310481 -                 ..
310482 -                [On 070201 UCSF advises that patients randomized for
310483 -                treatment with cetuximab alone need blood tests only to
310484 -                start a new cycle every 4 weeks, rather than weekly, as
310485 -                set out in the Consent documents. ref SDS 79 XR40
310487 -                 ..
310488 -                [On 080313 weekly blood tests required for Millie
310489 -                because treatment increased by adding Carboplatin to
310490 -                cetuximab treating 4th relapse of IBC. ref SDS 89 FW5N
310491 -
310492 -
310493 -
3105 -

SUBJECTS
Biopsies Optional Cancer Tumor Cetuximab Clinical Study Consent Form

3303 -
330401 -             ..
330402 -            Biopsies of Cancer Tumor Optional
330403 -
330404 -            If you have a tumor that can be safely biopsied, we will
330405 -            ask you to allow biopsy of that tumor before starting
330406 -            treatment and after 1-2 weeks of new treatment (either
330407 -            cetuximab by itself or cetuximab plus carboplatin).  This
330408 -            may involve up to 3 research biopsies, which we think are
330409 -            crucial to understanding why these drugs work in some
330410 -            patients but not in others.  The samples will be used to
330411 -            examine the effect the study drugs have on epidermal growth
330412 -            factor (EGFR), including what genes are altered by the
330413 -            treatment given in the study.  While you may not benefit
330414 -            from these biopsies, information we learn from your cancer
330415 -            may help us better treat women in the future.  You do not
330416 -            have to agree to have the biopsies taken to participate in
330417 -            this study. ref DRT 1 0348
330418 -
330419 -                 [On 070130 during a meeting with Doctor Rugo at UCSF,
330420 -                 Millie signed consent for optional biopsies to support
330421 -                 study objectives. ref SDS 77 M840
330423 -                  ..
330424 -                 [On 070131 UCSF decided not to perform biopsies in
330425 -                 order to avoid elevated risk of hemoraging while
330426 -                 Millie is being treated with Coumadin for pulmonary
330427 -                 embolism. ref SDS 78 IE8K
330429 -             ..
330430 -            Participating in the optional biopsy part of the study
330431 -            might involve the following risks and/or discomforts to
330432 -            you.  The risk of biopsy includes pain, swelling, bruising
330433 -            and bleeding.  Infection is always a possibility when the
330434 -            skin is broken, although this rarely occurs.  There may be
330435 -            specific risks depending on the location of the tumor and
330436 -            the type of biopsy being done.  Your study doctor will
330437 -            describe the risks associated with your biopsy in more
330438 -            detail. ref DRT 1 6P54
330439 -
330440 -
330442 -  ..
330443 - Questions and Planning to Start Treatment...
330444 -
330445 -
330446 -            [On 070117 Millie's letter to UCSF presents these
330447 -            questions. ref SDS 72 HT3Q
330448 -
330449 -    1.  Can treatments be given through the port catheter used for
330450 -        other intravenous treatments, and blood draws?
330451 -
330452 -
330453 -
330454 -
330455 -
3305 -

SUBJECTS
Cetuximab Side Effects Face Rash Acne-like Mild Fatigue Weakness Sho

3603 -
360401 -  ..
360402 - Side Effects Cetuximab Face Rash Fatigue Weakness Shortness Breath
360403 -
360404 -
360405 -    2.  Weekly treatments and side effects. ref DRT 1 AQ4W
360406 -
360407 -        Research on 061230 indicates side effects are "mild."
360408 -        ref SDS 64 PO5M
360410 -         ..
360411 -        Is there a typical patient profile, where side effects are
360412 -        tolerated well enough to continue working 3 days a week,
360413 -        Tuesday - Thursday?
360414 -
360415 -                [On 070117 side effects monitored by doctor during
360416 -                first few treatments. ref SDS 72 3E8J
360418 -         ..
360419 -        Should arrangements be made to take extended leave for the
360420 -        period of the drug trial in order that side effects do not
360421 -        disrupt daily work?
360422 -
360423 -                [On 070117 most patients tolerate side effects well
360424 -                enough to work regular schedule. ref SDS 72 QM7I
360426 -         ..
360427 -        If treatments can be given on Thursday afternoons, can side
360428 -        effects be expected to subside sufficiently by the following
360429 -        Tuesday to permit productive work on the job for a few days?
360430 -
360431 -            [On 070117 decided Millie will get treatments on Thursdays,
360432 -            and can revise her work schedule to fit treatments by
360433 -            working Monday-Wednesday, then taking Thursday off for
360434 -            treatment, and Friday off to recover from side effects.
360435 -            ref SDS 72 QM89
360437 -         ..
360438 -        Treatments last year beginning on 060721 with Taxotere and
360439 -        capecitabine, side effects were quite severe for 3 - 5 days,
360440 -        and then became tolerable for working the next 2 weeks until
360441 -        another treatment cycle began.  Weekly treatment with Cetuximab
360442 -        would not enable working if side effects are equally severe,
360443 -        because this protocol does not have a 2 week recovery period.
360445 -         ..
360446 -    3.  Cetuximab causes skin reactions such as an acne-like rash,
360447 -        drying, cracking, inflammation and infections. ref DRT 1 HW53
360449 -         ..
360450 -        Will Cetuximab side effects of rash and inflammation compound
360451 -        IBC rash?
360453 -         ..
360454 -        How will Cetuximab inflammation side effects be distinguished
360455 -        from Inflammatory Breast Cancer (IBC) rash?
360456 -
360457 -           [On 070130 meeting at UCSF discusses due diligence to avoid
360458 -           mistaking rash and inflammation side effects of cetuximab
360459 -           for Cellulitis, and concealing progression of IBC disease.
360460 -           ref SDS 77 RN8O
360462 -            ..
360463 -           [On 070330 inflammation increases on left arm diagnosed with
360464 -           IBC; Keflex prescribed to treat for possible compound
360465 -           problem of cellulitis, ref SDS 84 TT9J; intensity of rash
360466 -           subsides, so treatment was not taken. ref SDS 84 N75M
360468 -            ..
360469 -           [On 070419 Millie reports erratic IBC rash inflammation on
360470 -           left arm and upper right chest, ref SDS 85 F57K; UCSF
360471 -           explains skin rash only occurs to face, ref SDS 85 D39M,
360472 -           research on Internet seems to indicate skin inflammation and
360473 -           infections may occur at other locations which might compound
360474 -           IBC inflammation. ref SDS 85 RA5F
360476 -            ..
360477 -           [On 080411 increased rash on upper left arm, and on IBC
360478 -           sites on the chest attributed to cetuximab side effects the
360479 -           day after seeming full recovery from severe episode of
360480 -           Cellulitis treated at the hospital Emergency on 080410.
360481 -           ref SDS 90 V45J
360483 -         ..
360484 -        What is the recovery period after treatment ends with
360485 -        Cetuximab?  Does acne-like rash subside in a week, a month;
360486 -        does it last several years, or continue to worsen?
360487 -
360488 -           [On 070117 Jackie advised that UCSF experience shows many
360489 -           patients have mild reaction with acne-like rash, and that
360490 -           UCSF treats patients with medications that moderate this
360491 -           side effect. ref SDS 72 QM7I
360493 -            ..
360494 -           [On 070130 doctor indicates rash side effects of cetuximab
360495 -           only occurs on the face, and that UCSF has treatments to
360496 -           minimize side effects; may take several treatments to
360497 -           determine an effective level of medication for acne-like
360498 -           side effects. ref SDS 77 RN8O
360500 -            ..
360501 -           [On 070201 Brigid advised during follow up examination to
360502 -           start treatment at UCSF that medication to control acne-like
360503 -           side effects is provided a week after the 1st treatment, and
360504 -           if shown by examination to be required. ref SDS 79 FO66
360506 -         ..
360507 -    4.  Side effects for Cetuximab that occur approximately 20% can
360508 -        involve... ref DRT 1 HW54
360509 -
360510 -        •  tiredness/weakness
360511 -        •  fever
360512 -        •  nausea
360513 -        •  vomiting
360514 -        •  loss of appetite
360515 -        •  diarrhea
360516 -        •  constipation
360517 -        •  abdominal pain
360518 -        •  headache
360520 -         ..
360521 -    5.  Pulmonary embolism, blood clots in lung. ref DRT 1 Z68E
360522 -
360523 -        Wicked problems reviewed on 070622 shows cancer treatment, in
360524 -        this case cetuximab and carboplatin, can cause side effects
360525 -        that hide other symptoms.  Doctors mistake actual symptoms that
360526 -        require treatment for expected side effects and so fail to
360527 -        prescribe treatment of life threatening lung and heart
360528 -        disorders, blood clots, pulmonary embolism, and enlarged right
360529 -        ventricle. ref SDS 39 346F
360531 -         ..
360532 -        Doctor Rugo addressed patient status with pulmonary embolism in
360533 -        a letter to Kaiser reviewed on 061230.  Kaiser reported Millie
360534 -        is stable on treatment. ref SDS 64 PN6R  This aligns with
360535 -        Kaiser's report on 060110 that most recent INR is 2.3,
360536 -        ref SDS 69 5O6P,
360537 -
360538 -            [On 070130 Doctor Rugo presented plans for vigorous testing
360539 -            to reduce Millie's exposure to complications of pulmonary
360540 -            embolism and heart disorders from treatment with cetuximab
360541 -            clinical drug trial. ref SDS 77 456H
360543 -  ..
360544 - Research indicates lung and heart disorders may cause death in rare
360545 - cases....
360546 -
360547 -            Erbitux (Cetuximab) injection
360548 -
360549 -              http://www.erbitux.com/erbitux/erb/patient_crc/home/index.jsp?BV_SessionID=@@@@0323146626.1181068929@@@@&BV_EngineID=cccdaddkfkmighgcfkjcemndfnidfin.0
360551 -  ..
360552 - Consent document continues...
360553 -
360554 -    6.  Cardiopulmonary arrest (heart attack) was seen in 2% of people
360555 -        with head and neck cancer who were having radiation treatment
360556 -        while receiving cetuximab. ref DRT 1 G58J
360558 -         ..
360559 -        CT test on 060930 showed heart disorder enlarged right
360560 -        ventricle (Cor Pulmonale, reviewed on 061012.
360562 -         ..
360563 -    7.  Cetuximab may cause a serious lung condition called
360564 -        interstitial lung disease (ILD) that results in inflammation,
360565 -        scarring and hardening of the lungs.  Interstitial lung disease
360566 -        has been reported in fewer than 1% of patients treated with
360567 -        cetuximab.  Notify your doctor immediately if you develop
360568 -        shortness of breath while receiving cetuximab. ref DRT 1 0256
360570 -         ..
360571 -        Shortness of breath is a symptom of pulmonary embolism, and of
360572 -        enlarged right ventricle, diagnosed in Millie's case by the CT
360573 -        test on 060930, and reviewed on 061012. ref SDS 47 LG9L
360574 -
360575 -            [On 070329 CT test on 070326 reports finding no
360576 -            interstitial lung disease. ref SDS 83 5S6L
360578 -             ..
360579 -            [On 080723 Interstitional Lung disease reported in findings
360580 -            for CT test on 0080718. ref SDS 92 TS4J
360582 -             ..
360583 -            [On 080723 case study shows patient history of
360584 -            interstitional lung disease. ref SDS 92 7W6F
360586 -             ..
360587 -            [On 080821 meeting with medical team, there was no
360588 -            discssion of CT test performed 080718 finding Interstitial
360589 -            lung disease. ref SDS 93 056G
360591 -             ..
360592 -            [On 080829 during a meeting at Kaiser the primary care
360593 -            physician used the computer in the Examination room to open
360594 -            files for the CT test on 080718; after examination CT scan
360595 -            files the doctor commented that Interstitional lung disease
360596 -            reported on 080723, ref SDS 92 TS4J, appears very mild and
360597 -            not a significant side effect of cetuximab treatment for
360598 -            Millie's cancer. ref SDS 94 RP4X
360600 -             ..
360601 -            [On 080912 report on follow up CT test the day before on
360602 -            080911 makes no findings of "Interstitional lung disease,"
360603 -            but may be reported with different language. ref SDS 91
360604 -            TS4J
360606 -             ..
360607 -            [On 081017 Millie starting new treatment with sunitinib
360608 -            protocol that includes cyclophosphamide (Cytoxan), and
360609 -            which has rare, serious side effect of Interstitial
360610 -            pneumonitis. ref SDS 95 AR3W
360612 -             ..
360613 -            [On 081112 CT test on 0811107 finds Interstitional disease
360614 -            at higher levels than shown by CT test on 080718.
360615 -            ref SDS 96 TS4J
360617 -         ..
360618 -    8.  Trip to Seattle is scheduled for Wednesday, 070124, with return
360619 -        on Friday, 070126.  One idea would be to advance departure to
360620 -        Tuesday, 070123, and return on Thursday 070125.  The most
360621 -        recent PT/CT test was on 061227.  Could treatment then start on
360622 -        Friday, 070126 and still meet protocol requirements?
360623 -        Alternatively, the trip can be deferred entirely, if required
360624 -        to get off to a good start with the new treatment regimen.
360625 -
360626 -            [On 070117 Millie decided to cancel trip to Seattle to
360627 -            accomodate UCSF work and planning for treating Millie
360628 -            beginning on 070124, ref SDS 72 5S82; Millie's letter to
360629 -            UCSF confirms cancelling the trip to Seattle. ref SDS 72
360630 -            5F9W
360632 -             ..
360633 -            [On 070119 treatment at UCSF delayed, ref SDS 73 AS96, and
360634 -            scheduled to start until 070123 or 070124. ref SDS 73 AS5H
360636 -             ..
360637 -            [On 070123 treatment by UCSF seems on hold or cancelled
360638 -            without Kaiser and Medicare authorization, ref SDS 74 J43I,
360639 -            Millie decides make the trip to Seattle for a few days.
360640 -            ref SDS 74 PUPV
360642 -             ..
360643 -            [On 070124 Millie travels to Seattle after treatment is
360644 -            delayed; implements original plans today. ref SDS 75 KX9H
360646 -         ..
360647 -    9.  Dental work to replace a bridge is scheduled for Monday,
360648 -        070122, in Embarcadero Two.  Previously, major dental work has
360649 -        not been done when being treated with chemotherapy.  There will
360650 -        be a follow up visit the following week to install the new
360651 -        bridge.  Will this present a conflict with the clinical trial
360652 -        protocol?  Should the dental work be deferred?
360654 -  ..
360655 - Dental work was eventually performed on 070122.
360656 -
360657 -
360658 -
360659 -
360660 -
360661 -
360662 -
360663 -
360664 -
3607 -