CONTACTS 

SUBJECTS
Questions Consent Forms Cetuximab Carboplatin Triple Negative Study

1803 -
1803 -    ..
1804 - Summary/Objective
1805 -
180501 - Follow up ref SDS 68 0000. ref SDS 66 0000.
180502 -
180503 - Millie submitted a letter confirming understandings on plans to start
180504 - treatment at UCSF on Friday, 070119. ref SDS 0 1G3K  Jackie called in
180505 - the afternoon.  She did not receive Millie's letter.  Further attempts
180506 - to transmit communications with the Internet failed. ref SDS 0 Y25Q
180507 - Reviewed Millie's questions on Cetuximab Carboplatin Clinical Drug
180508 - Trial.  Jackie suggests starting treatment on Friday, 070119, rather
180509 - than waiting to next week on 070124, as initially proposed yesterday.
180510 - Millie approved this change in the schedule. ref SDS 0 5S85  Developed
180511 - plans for Millie to change her work schedule from Tuesday - Thursday,
180512 - to Monday - Wednesday.  She can then get treatments at UCSF on
180513 - Thursdays which will fit with Doctor Rugo's schedule. ref SDS 0 QM89
180514 - Jackie submitted a letter confirming understandings, ref SDS 0 0346,
180515 - and asking about arrangements for payment. ref SDS 0 LY4Y  Millie sent
180516 - a response reporting background that indicates payment issues have
180517 - been previously settled for Kaiser to pay for any costs not covered in
180518 - the trial program. ref SDS 0 5F4R  Millie also notified the primary
180519 - care physician at Kaiser about plans for starting treatment next week
180520 - on 070126. ref SDS 0 638H
180521 -
180522 -
180523 -
180524 -
180526 -  ..
1806 -
1807 -
1808 - Progress
1809 -
180901 - Cetuximab Carboplatin Clinical Drug Trial UCSF Initial Discussion
180902 -
180903 - Follow up ref SDS 68 1G3K, ref SDS 66 1G3K.
180904 -
180905 - Millie submitted ref DIT 1 0001 responding to UCSF's letter from
180906 - Jackie yesterday, on 070116. ref SDS 68 RT7K
180908 -  ..
180909 - Letter to UCSF says...
180910 -
180911 -    1.  Thanks very much for timely submission of the consent form to
180912 -        get me started on treatment next week, as related in your
180913 -        letter yesterday, shown below. ref DIT 1 0001
180915 -         ..
180916 -    2.  I would like to shoot for starting treatment OA 070124 so that
180917 -        I do not need another PET or CT test, as explained in your
180918 -        letter. ref SDS 68 428N, ref DIT 1 LS5O
180920 -         ..
180921 -    3.  Please comment on initial questions listed in the record
180922 -        reviewing your letter. ref SDS 68 I662, ref DIT 1 RT6I
180924 -  ..
180925 - This includes primary side effects of cetuximab that affect mostly the
180926 - skin, i.e., rash that could be confused for IBC, ref SDS 68 MH4Q, and
180927 - others including fatigue, leading to shortness of breath, that could
180928 - prevent recognizing symptoms of pulmonary embolism. ref SDS 68 O64M
180929 -
180930 -             [...below, Jackie seems to indicate these issues have been
180931 -             problems with other patients. ref SDS 0 QM7I
180933 -              ..
180934 -             [On 070130 doctor indicates that rash side effects of
180935 -             cetuximab only occurs on the face, and that UCSF has
180936 -             treatments to minimize side effects; may take several
180937 -             treatments to determine an effective level of medication
180938 -             for acne-like side effects. ref SDS 72 RN8O
180940 -  ..
180941 - Letter to UCSF continues...
180942 -
180943 -    4.  If it is easier, you can call me at ************ to discuss
180944 -        these issues. ref DIT 1 IT6O
180946 -         ..
180947 -    5.  Thanks again for helping me get started with treatment.
180948 -        ref DIT 1 TT7H
180950 -         ..
180951 -    6.  I look forward to meeting Doctor Rugo, you, and the UCSF team.
180952 -        ref DIT 1 8U7K
180954 -         ..
180955 -    7.  Post Script
180957 -         ..
180958 -        By copy to Arlette at Kaiser, I am keeping my primary care
180959 -        physician, **************, apprised of communications and
180960 -        planning. ref DIT 1 00W2
180961 -
180962 -
180963 -
180965 -  ..
1810 -
1811 -
1812 - 1346
1813 -
181301 - Called Jackie to discuss questions on Consent form and scheduling
181302 - start of treatment.  Left message for Jackie to call back.
181303 -
181304 -
181306 -  ..
1814 -
1815 -
1816 - 1643
1817 -
181701 - Jackie called back.
181702 -
181703 - For some reason she has not received Millie's letter, submitted
181704 - earlier this morning, per above. ref SDS 0 1G3K
181706 -  ..
181707 - Since the letter has not bounced back, this suggests she should have
181708 - received it.  Tried several more times, including sending a test
181709 - letter.  Jackie got the test letter, but not the actual letter.
181710 -
181711 -     [On 070118 Jackie received Millie's letter, indicating problem
181712 -     with electronic correspondence system (email) has been resolved.
181713 -     ref SDS 69 1G3K
181715 -      ..
181716 -     [On 070119 Jackie received Millie's letters that did not transmit
181717 -     today, indicating email address is correct. ref SDS 70 1G3K
181718 -
181720 -  ..
181721 - Side Effects Tolerated Do Not Impede Normal Work for Most Patients
181722 - First Few Treatments Doctor Monitors Patient Tolerance Side Effects
181723 -
181724 - We discussed Millie's questions on the clinical study, which are
181725 - listed in the record on 070116. ref SDS 68 I662
181727 -  ..
181728 - Initial impression is that side effects will likely enable Millie to
181729 - continue working, answering questions on 070116. ref SDS 68 5L3H
181730 - Jackie explained that UCSF will prescribe medication to prevent side
181731 - effects of acne-like rash. ref SDS 68 MH4Q
181733 -         ..
181734 -        [On 070130 doctor indicates rash side effects of cetuximab only
181735 -        occurs on the face, and that UCSF has treatments to minimize
181736 -        side effects; may take several treatments to determine an
181737 -        effective level of medication for acne-like side effects.
181738 -        ref SDS 72 RN8O
181740 -         ..
181741 -        [On 070201 Brigid advised during follow up examination to
181742 -        start treatment at UCSF that medication to control acne-like
181743 -        side effects is provided a week after the 1st treatment, and
181744 -        if shown by examination to be required. ref SDS 73 FO66
181746 -  ..
181747 - Jackie explained that the first 2 - 3 treatments will be given over a
181748 - longer period, so that a doctor can monitor Millie's reaction for
181749 - severe side effects.  After the first few treatments, normal rate of
181750 - drip will treatment will be used, and take about an hour.
181752 -  ..
181753 - UCSF will accomodate Millie's schedule for taking a trip next week,
181754 - answering the question on 070116. ref SDS 68 VQ3G
181756 -  ..
181757 - Actually, after the call, Millie decided to defer the trip to reduce
181758 - the burden all around of balancing a hectic schedule.
181759 -
181760 -        [...below, Millie notifies Jackie about cancelling the trip;
181761 -        and giving UCSF greater flexibility to schedule work with
181762 -        Millie to accomodate Doctor Rugo's schedule. ref SDS 0 5F9W
181764 -         ..
181765 -        [On 070124 Millie travels to Seattle after treatment is
181766 -        delayed; implements original plan. ref SDS 71 KX9H
181768 -  ..
181769 - Jackie proposed scheduling treatment to start this Friday, 070119,
181770 - rather than next week?  Millie feels this is a good idea to provide
181771 - time to resolve problems that might occur and still enable treatment
181772 - without incurring delay and discomfort of getting another PET/CT test,
181773 - noted by Doctor Rugo, and cited in Jackie's letter yesterday on
181774 - 070116. ref SDS 68 428N
181776 -  ..
181777 - Jackie agreed.  She is waiting to get approval from one more source
181778 - for Millie to be treated in the drug trial; she expects to get that
181779 - tomorrow or Friday.
181781 -  ..
181782 - When Millie meets with Doctor Rugo in the next few days, the doctor
181783 - will let Millie know if she can go ahead with planned dental work,
181784 - cited in the record on 070116. ref SDS 68 VQ3U
181785 -
181786 -
181787 -
1818 -

SUBJECTS
Thursday Millie's Treatment Schedule at UCSF Revise Work Schedule fo

3303 -
330401 -  ..
330402 - N&P Work Schedule Revised Monday - Wednesday Treatment Thursday
330403 - Thursday Set Millie's Regular Treatment Day Revise Work Schedule
330404 -
330405 - Jackie explained that Doctor Rugo can support Millie with treatments
330406 - on Thursdays, which is her regular clinic day for seeing patients.
330407 - (see Jackie's confirmation letter, below. ref SDS 0 0346)
330409 -  ..
330410 - Millie will revise her schedule to work Monday - Wednesday, and take
330411 - Thursday and Friday off.  This will give her 3 days to recover from
330412 - side effects in order to be effective on the job Monday - Wednesday.
330414 -  ..
330415 - There is some experimentation that will occur.  After Millie gets
330416 - experience to see how she feels, and after the initial few treatments
330417 - that will take longer for monitoring tolerance of side effects, it
330418 - might be possible for millie to get treatments at 1700 or say 1630.
330419 - She could then work her regular schedule Tuesday - Thursday if that
330420 - turns out to be more convenient for N&P, and if Millie likes that
330421 - schedule better.
330422 -
330423 -
330424 -
330425 -
330427 -  ..
3305 -
3306 -
3307 - 2133
3308 -
330801 - UCSF Confirms Plans to Start Treatment 070119 Switch to Thursdays
330802 -
330803 - Millie received ref DRT 2 0001 from Jackie confirming understandings
330804 - from telecon earlier this afternoon, per above. ref SDS 0 Y25Q
330806 -  ..
330807 - Jackie's letter to Millie...
330808 -
330809 -    1.  Per our conversation, I will check with Dr. Rugo to see if it
330810 -        is possible for Millie to start treatment on Friday.  Her
330811 -        clinic days are on Tuesday and Thursday, but I will check her
330812 -        availability due to the timing of the PET/CT and your upcoming
330813 -        trip.
330815 -         ..
330816 -    2.  I will also let Dr.  Rugo know that Millie is having a bridge
330817 -        done on Monday, and ask her if it OK for Millie to have
330818 -        treatment this Friday.  I will try to get an answer to you
330819 -        sometime tomorrow. ref DRT 2 9K6F
330821 -  ..
330822 - Business Arrangements Kaiser Pays for Standard of Care
330823 -
330824 -
330825 -    3.  Also, do you have approval from Kaiser to come to UCSF?  Please
330826 -        let me know if you need help obtaining this approval.  The
330827 -        trial only provides the cost of cetuximab.  Everything else
330828 -        (such as visits, labs, carboplatin) will be billed to insurance
330829 -        since it is considered standard of care.  Scans can still be
330830 -        done at Kaiser. ref DRT 2 BK6K
330832 -  ..
330833 - On 061230, Doctor Rugo secured approval from Millie's primary care
330834 - physician at Kaiser for treating Millie at UCSF, and advised that
330835 - Kaiser will pay for any costs not covered by the trial. ref SDS 60
330836 - 3X6K   This is explained in Millie's response to Jackie, per below.
330837 - ref SDS 0 5F4R
330839 -  ..
330840 - Jackie's letter to Millie concludes...
330841 -
330842 -    4.  Please let me know if you have any questions. ref DRT 2 KK7H
330843 -
330844 -
330845 -
330847 -  ..
3309 -
3310 -
3311 - 2258
3312 -
331201 - Kaiser Agreed Pay Any Costs Not Covered by Trial
331202 -
331203 - Millie submitted ref DIT 3 0001 responding to UCSF's letter from
331204 - Jackie, ref DRT 2 0001, received earlier this afternoon, per above,
331205 - ref SDS 0 0346,
331207 -  ..
331208 - Millie's letter to UCSF says...
331209 -
331210 -    1.  Good work in your letter today. ref SDS 0 0346  Your letter
331211 -        aligns well with the discussion aiming to start treatment at
331212 -        UCSF on 060119, per above. ref SDS 0 Y25Q
331214 -         ..
331215 -    2.  After your call, I decided to cancel the trip planned for
331216 -        060124, cited in questions listed on 070116. ref SDS 68 VQ3G
331217 -        This gives you more flexibility scheduling my case to fit
331218 -        Doctor Rugo's schedule. ref DIT 3 4G6K
331219 -
331220 -           [On 070124 Millie travels to Seattle after treatment is
331221 -           delayed; implements original plan. ref SDS 71 KX9H
331223 -         ..
331224 -    3.  With respect to approval from Kaiser for UCSF to provide
331225 -        treatment, my primary care physician, ..., made all the
331226 -        arrangements with Doctor Rugo, pursuant to planning on 061208.
331227 -        ref SDS 52 D58F, ref DIT 3 FG7F
331229 -         ..
331230 -    4.  On 061230, I received a letter dated 061229 from [my doctor] at
331231 -        Kaiser, and showing that Doctor Rugo asked about payment for
331232 -        standard of care.  [My doctor] told Doctor Rugo in a reply (his
331233 -        comments are in parentheses) that Kaiser will pay for any costs
331234 -        not covered by the trial. ref SDS 60 3X6K, ref DIT 3 GH7M
331236 -         ..
331237 -    5.  I notified [my doctor] yesterday about initial plans for
331238 -        treatment at UCSF to start OA 070124, and he responded today,
331239 -        saying simply "Great!" ref SDS 0 638H, ref DIT 3 TI8K
331241 -         ..
331242 -    6.  I assume UCSF and Kaiser can make necessary business
331243 -        arrangements.  Please let me know if you need me to do anything
331244 -        further on this matter. ref DIT 3 TI9G
331246 -         ..
331247 -    7.  Thanks so much for your assistance. ref DIT 3 MK9L
331249 -         ..
331250 -    8.  Look forward to your call tomorrow finalizing arrangements.
331251 -        ref DIT 3 WK9O
331252 -
331253 -
331254 -
331255 -
331256 -
331257 -
3313 -

SUBJECTS
Notify Kaiser Oncology Progress Scheduling Treatment UCSF Cancer Cen

4603 -
4604 - 1137
460501 -  ..
460502 - Kaiser Advised UCSF Making Progress Starting Millie Clinical Trial
460503 -
460504 - Follow up ref SDS 66 II4R, ref SDS 64 V84T.
460505 -
460506 - Millie submitted ref DIT 2 0001 to the primary care physician at
460507 - Kaiser saying...
460508 -
460509 -    1.  Finally, I got a call from UCSF trial coordinator yesterday
460510 -        afternoon. ref SDS 68 NK8F  They want me to start treatment
460511 -        next week, and will schedule a meeting with Doctor Rugo between
460512 -        now and then. ref SDS 68 428N  They sent the consent forms by
460513 -        email, and today I sent back a few questions. ref SDS 0 HT3Q
460514 -        I'm mostly worried about side effects, and whether I can keep
460515 -        working with treatments once a week. ref SDS 68 7Y4H
460516 -
460517 -            [...above, telecon with Jackie at UCSF comments on side
460518 -            effect issues. ref SDS 0 QM7I
460520 -  ..
460521 - Millie's letter to primary care physician at Kaiser concludes...
460522 -
460523 -    2.  Thanks very much for pushing this forward.
460525 -  ..
460526 - Millie's letter on 070109 asked the doctor to exedite consideration by
460527 - UCSF. ref SDS 64 V84T  On 070110 the doctor submitted a letter showing
460528 - correspondence sent to Doctor Rugo to get Millie enrolled for
460529 - treatment at UCSF in a clinical drug study. ref SDS 65 NM4O
460530 -
460531 -
460532 -
460534 -  ..
4606 -
4607 -
4608 - 1418
4609 -
460901 - Millie received ref DRT 1 0001 from primary care physician at Kaiser
460902 - responding the the letter this morning, ref DIT 2 0001, notifying
460903 - Kaiser that UCSF has contacted Millie about starting treatment next
460904 - week, per above. ref SDS 0 638H
460906 -  ..
460907 - The doctor says...
460908 -
460909 -        Great! ref DRT 1 0001
460910 -
460911 -    [...above, notified UCSF that primary care physician at Kaiser has
460912 -    approved payment for standard of care on Millie's treatment by
460913 -    UCSF. ref SDS 0 LY4Y
460914 -
460915 -
460916 -
460917 -
460918 -
460919 -
460920 -
460921 -
460922 -
460923 -
4610 -