Melanoma Clinical Trial
Official title:
A Two Arm Phase II Trial of Sequential Axitinib and Carboplatin/Paclitaxel in Melanoma With Correlative FLT PET Scans (3'Deoxy-3'-18F-Fluorothymidine Positron Emission Tomography Scans)(CC# 10852)
This is a two arm prospective Phase II pilot trial designed to determine the optimal duration of break between axitinib and chemotherapy with carboplatin/paclitaxel in melanoma. In this study, 6 patients will be enrolled to Arm A, the FLT PET scan (3'deoxy-3'-18F-Fluorothymidine positron emission tomography scans)cohort. 30 patients will be enrolled to Arm B, the treatment-only cohort. 36 total patients will be enrolled. The treatment schedule will be the same in either cohort, with the exception of the FLT PET scans.
This is a two arm prospective Phase II pilot trial designed to determine the optimal duration
of break between axitinib and chemotherapy with carboplatin/paclitaxel in melanoma. In this
study, 6 patients will be enrolled to Arm A, the FLT-PET (3'deoxy-3'-18F-Fluorothymidine
positron emission tomography scans)cohort. 30 patients will be enrolled to Arm B, the
treatment-only cohort. 36 total patients will be enrolled. The treatment schedule and dose
will be the same in either cohort, with the exception of the FLT PET scans. We are enrolling
only 6 patients to Arm A, the FLT-PET cohort, because of study financial considerations.
Patients will be enrolled in Arm A first, the FLT-PET cohort, to accommodate the radiological
manufacture of the FLT-PET scan dye. It is expensive to manufacture and it is not usable
forever. However if a patient is unable to participate in Arm A because of logistical issues,
i.e. not being able to travel to UCSF for FLT-PET scans we will offer them participation in
Arm B so that they can receive treatment that is not available off study.
Each treatment cycle will last for 21days. During Cycle 1, patients will be treated with:
Days 1-14: axitinib 5 mg PO twice daily Days 15-21: break from treatment
In all cycles after Cycle 1, patients will be treated with:
Day 1: paclitaxel 175 mg/m2 over 3 hours followed by carboplatin AUC 5 (AUC 5 is a term used
to describe the dosing of carboplatin based on a patient's height, weight and kidney
function) over 45 minutes Days 1-14: axitinib 5 mg PO twice daily Days 15-21: break from
treatment Arm A: FLT PET cohort subjects will have FLT PET scans up to 2 weeks prior to day 1
and on days 14, 17, and 21 of cycle 1.
Arm B: Treatment-only patients will receive administration of axitinib and
carboplatin/paclitaxel on the same schedule and dose as Arm A but will not have FLT PET
scans. Patients in Arm B will have standard tumor assessment with FDG PET-CT scans
(F18-deoxyglucose positron emission tomography scans), CT Scans, and MRI's.
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