A Pilot Study of Vemurafenib and Panitumumab in Patients with BRAF V600E-Mutated Metastatic Colorectal Cancer

Protocol
12-221
Full Title
A Pilot Study of Vemurafenib and Panitumumab Combination Therapy in Patients with BRAF V600E Mutated Metastatic Colorectal Cancer
Phase
Pilot
Purpose

The purpose of this study is to assess the safety and preliminary effectiveness of combining two drugs — vemurafenib and panitumumab — in patients with metastatic colorectal cancer that contains the V600E mutation in the BRAF gene and has stopped responding to standard therapies. Both drugs are approved by the FDA, but their use together is considered investigational.

Vemurafenib is approved for treating metastatic melanoma. It works by inhibiting the activity of BRAF, a protein which, when mutated, drives the growth of cancer. Vemurafenib is approved specifically for patients with the V600E mutation in the BRAF gene. It is taken orally (by mouth).

Panitumumab is approved for treating advanced colorectal cancer. It works by binding to and blocking a protein called epidermal growth factor receptor. It is given intravenously (by vein). Prior studies have suggested that vemurafenib given alone is not effective against colorectal cancer, but that giving it with panitumumab may help it to work better against colorectal tumors that contain the V600E BRAF mutation.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic colorectal cancer that contains the V600E mutation in the BRAF gene and has stopped responding to standard therapies.
  • Patients may not have previously received panitumumab or cetuximab, but any number of other prior therapies is permitted.
  • At least 3 weeks must have passed since completion of prior chemotherapy or radiation therapy and 4 weeks since any major surgery and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Rona Yaeger at 646-888-4179.

Disease(s)
Colorectal Cancer
Locations
Related Diseases