The purpose of this study is to test a new drug combination consisting of two drugs, vemurafenib (also known as ZelborafTM) and panitumumab (also known as VectibixTM). This treatment is being tested in a subgroup of patients with colorectal cancer whose tumors have changes in the BRAF gene that may make them more likely to respond to this new drug combination.
Name: combination panitumumab and vemurafenib
Description: Treatment will consist of panitumumab 6mg/kg IV every 14 days and vemurafenib 960mg orally twice daily. In patients who initially respond to treatment and later progress, a voluntary biopsy will be requested at the time of relapse to study mechanisms of acquired resistance. This biopsy should consist of at least one frozen core specimen. Every effort will be made to obtain this biopsy within 30 days of discontinuation of treatment and before the initiation of any new tumor-directed therapies.Type: Drugcombination panitumumab and vemurafenib
Description: Overall response will be estimated based on best response to this combination in six months of treatment.
Measure: objective response rate (ORR) Time: 6 monthsDescription: Progression free survival (PFS) is defined as the period elapsing between the date of initiation of therapy and the date of either disease progression or date of death, whichever is earlier.
Measure: progression-free survival (PFS) Time: 2 yearsDescription: OS is defined as the interval between the time of initiation of therapy and the date of death from any cause. Patients who are alive at the time of study completion will be censored at the time the patient was last known to be alive.
Measure: overall survival (OS) Time: 2 yearsDescription: The safety endpoints will include all types of adverse experiences, laboratory safety measurements, ECOG performance scale status, and vital signs. Adverse experiences will be graded and recorded throughout the study according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.
Measure: safety, tolerability, and adverse event profile Time: 1 yearDescription: using pre- and post-vemurafenib tumor biopsies obtained from the first 10 patients participating in this trial.
Measure: efficacy Time: 2 yearsSingle Group Assignment
There is one SNP
A Pilot Study of Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer. --- V600E ---
Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer The purpose of this study is to test a new drug combination consisting of two drugs, vemurafenib (also known as ZelborafTM) and panitumumab (also known as VectibixTM). --- V600E ---
using pre- and post-vemurafenib tumor biopsies obtained from the first 10 patients participating in this trial.. Inclusion Criteria: - Patient must have metastatic colorectal cancer with a V600E BRAF mutation that has been histologically or cytologically-confirmed at MSKCC and has failed to respond to appropriate standard therapy regimens. --- V600E ---
Inclusion Criteria: - Patient must have metastatic colorectal cancer with a V600E BRAF mutation that has been histologically or cytologically-confirmed at MSKCC and has failed to respond to appropriate standard therapy regimens. --- V600E ---