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
(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
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the Objective Response Rate (ORR) of axitinib + carboplatin/paclitaxel in metastatic melanoma.
The primary outcome measure will be assessed by radiographic response using RECIST criteria during every 21 day cycle of treatment.
Adil Daud, MD
Cutaneous Oncology Group at the Helen Dillar Family Comprehensive Cancer Center at UCSF
United States: Food and Drug Administration
|Cutaneous Onocology Group at the Helen Dillar Family Comprehensive Cancer Center UCSF||San Francisco, California 94115|