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Sunitinib Clinical Study Drug Trial Consent  Dcument 080828 Data Ent

0903 -
0903 -    ..
0904 - Summary/Objective
0905 -
090501 - Follow up ref SDS 9 0000, ref SDS 7 0000.
090502 -
090503 -
090504 -
090505 -
090506 -
090508 -  ..
0906 -
0907 -
0908 - Progress
0909 -
090901 - Sunitinib Clinical Study Consent Data Entry Command Control Record
090902 -
090903 - Follow up ref SDS 9 HF5H, ref SDS 7 J34R.
090904 -
090905 - On 081016 Doctor Rugo identified possible progression of cancer based
090906 - on increased intensity on Millie's left arm, and swelled lymph node in
090907 - the left supraclavicular identified by palpation at UCSF on 080821,
090908 - ref SDS 4 4C6O, again on 080829 by the primary care physician at
090909 - Kaiser, ref SDS 5 RP8T, and again at UCSF on 081016 by Brigid.
090910 - ref SDS 7 J34X
090912 -  ..
090913 - At that time the doctor proposed treatment in a new clinical trial
090914 - using Sunitinib. ref SDS 7 J38U
090916 -  ..
090917 - During treatment in the Infusion Clinic, Glenna, the coordinator, for
090918 - the Sunitinib study, delivered a printed Consent document, ref OF 1
090919 - 0001, to Millie while she was getting treatment in the Infusion Clinic
090920 - for cancer with the cetuximab clinical study. ref SDS 6 KV4O
090922 -  ..
090923 - Millie's letter to the medical team on 081016 planned to submit the
090924 - Consent documents to the primary care physician in order to prepare
090925 - for a meeting with Millie on 081024. ref SDS 7 J34R
090927 -  ..
090928 - On 081017, Millie entered the consent document, ref OF 1 0001, into
090929 - the record for case management. ref SDS 9 4E88
090931 -  ..
090932 - Earlier today, the doctor made arrangements with the Surgery
090933 - Department for Millie to get a biopsy of the node in the left
090934 - supraclavicular, ref SDS 13 YR6O, ordered by Doctor Rugo on 081016 for
090935 - the work plan to qualify Millie to get treatment with the Sunitinib
090936 - clinical trial. ref SDS 7 J36R  Coordination with Kaiser resulted in
090937 - changing the work to the Head and Neck Department, because Doctor Rugo
090938 - Ordered FNA, and this work is done in Head and Neck, rather than
090939 - Surgery. ref SDS 13 03GE  Millie sent a letter to the primary care
090940 - physician notifying of this change and requesting support contacting
090941 - the Head and Neck Department tomorrow about expediting the work in an
090942 - attempt to get the FNA and status check work done in time to review
090943 - results while meeting with the primary care physician on Friday,
090944 - 081024, to consider the UCSF proposal for Millie to enter the
090945 - Sinitinib clinical trial. ref SDS 14 XK79
090947 -  ..
090948 - This eventing, Millie sent another letter to the primary care
090949 - physician transmitting the patient Consent documents for the Sunitinib
090950 - clinical trial, planned in the letter to the medical team on 081016,
090951 - and in order for the doctor to be prepared to conduct a productive
090952 - meeting on 081024. ref SDS 7 J34R
090954 -  ..
090955 - Millie submitted the following letter...
090956 -
090957 -    1.  Subject: Sunitinib Clinical Study Consent Documents
090958 -        Date: Tue, 21 Oct 2008 20:27:53 -0700
090965 -         ..
090966 -    3.  This past Thursday, on 081016, Doctor Rugo gave me a Consent
090967 -        document for the sunitinib clinical trial. ref SDS 6 KV4O
090969 -         ..
090970 -    4.  There is a review on 081017 of specific issues linked into the
090971 -        Consent document. ref SDS 9 YX9N
090973 -         ..
090974 -    5.  Some of my questions were addressed, if not resolved, by
090975 -        comments at the Wellness Community seminar this past
090976 -        Saturday... 081018, ref SDS 10 PQ6X
090978 -  ..
090979 - Millie cites favorable comments by Doctor Stritter during seminar last
090980 - Saturday on 081018, and submitted to the primary care physician at
090981 - Kaiser on 081019. ref SDS 11 DZ6X
090982 -
090983 -            [On 081024 primary care phsyician prescribes treatment for
090984 -            Millie at UCSF with sunitinib metronomic and multi-agent
090985 -            protocol, ref SDS 16 XZ8W, because Millie's advancing
090986 -            cancer has become resistant to chemotherapy and so requires
090987 -            double agent drugs, and Kaiser only has single agent
090988 -            treatments which will be ineffective to treat Millie's 5th
090989 -            relapse of IBC, and further, becauser Kaiser's experience
090990 -            with sunitinib indicates this can be effective for Millie.
090991 -            ref SDS 16 ER4I
090993 -  ..
090994 - Millie's letter to Kaiser continues...
090995 -
090996 -    6.  The Consent document by itself is at... ref OF 1 0001
090998 -         ..
090999 -    7.  I typed this up from papers UCSF submitted on Thursday.  Took
091000 -        about 4 hours, so I missed hiking that day.  I replaced bullets
091001 -        with numbers for lists to facilitate discussion.  Everything
091002 -        else is the same.
091004 -         ..
091005 -    8.  I'll bring the paper on Friday for your file.  Let me know if
091006 -        you need it sooner.
091007 -
091008 -           [On 081022 Millie hand carried a printed copy of Consent
091009 -           document to primary care physician at Kaiser in Walnut
091010 -           Creek to prepare for meeting to review sunitinib clinical
091011 -           study and consider approval for this treatment. ref SDS 15
091012 -           XK5H
091014 -            ..
091015 -           [On 081024 Millie reviewed sunitinib clinical study consent
091016 -           document with primary care physician at Kaiser, and the
091017 -           doctor approved this treatment for Millie on referral at
091018 -           UCSF, ref SDS 16 XZ8W;
091019 -
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091028 -
091029 -
091030 -
091031 -
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0911 -