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A Two Arm Trial of Axitinib and Carboplatin/Paclitaxel in Melanoma

NCT01174238 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-06-08

Study results available
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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.

Conditions

Interventions

DRUG

Axitinib

5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy

DRUG

Carboplatin

Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase

DRUG

Paclitaxel

Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.

Sponsors & Collaborators

  • Adil Daud

    lead OTHER

Principal Investigators

  • Adil Daud, MD · Cutaneous Oncology Group at the Helen Dillar Family Comprehensive Cancer Center at UCSF

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-08-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01174238 on ClinicalTrials.gov