Clinical trial NCT01174238
Conditions: Melanoma
Keywords: Melanoma Axitinib Carboplatin Paclitaxel
Sponsor: Adil Daud
Start date: 2010-07-01; Completion date: 2013-12-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Patients enrolled in Arm A and Arm B will receive the same treatment with study drugs axitinib, carboplatin, and paclitaxel. Patients enrolled in Arm A and Arm B will have tumor imaging assessments: PET-CT, CT Scan, and/or MRI. In addition patients enrolled in Arm A will also have FLT-PET scans. arm 2: Patients enrolled in Arm A and Arm B will receive the same treatment with study drugs axitinib, carboplatin, and paclitaxel. Patients enrolled in Arm A and Arm B will have tumor imaging assessments: PET-CT, CT Scan, and/or MRI. Patients enrolled in Arm B will not have FLT-PET scans.
Interventions: intervention 1: Axitinib intervention 2: Carboplatin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy intervention 2: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase intervention 3: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.

Protocol documents: