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). 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer|
- objective response rate (ORR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Overall response will be estimated based on best response to this combination in six months of treatment.
- progression-free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- safety, tolerability, and adverse event profile [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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.
- efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]using pre- and post-vemurafenib tumor biopsies obtained from the first 10 patients participating in this trial.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: combination panitumumab and vemurafenib
This will be a pilot study of the combination panitumumab and vemurafenib in patients with metastatic colorectal cancer with a BRAF V600E mutation. Patients participating in this study must have BRAF V600E mutated metastatic colorectal cancer and not previously received treatment with an anti-EGFR targeting antibody (cetuximab or panitumumab).
Drug: combination panitumumab and vemurafenib
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791309
|Contact: Rona Yaeger, MD||646-888-4179|
|Contact: Leonard Saltz, MD||646-888-4181|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Rona Yaeger, MD 646-888-4179|
|Contact: Leonard Saltz, MD 646-888-4181|
|Principal Investigator: Rona Yaeger, MD|
|Principal Investigator:||Rona Yaeger, MD||Memorial Sloan-Kettering Cancer Center|