Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colon Cancer
The purpose of this screening step is to perform a genetic test on your colorectal cancer tumor sample to see if it has a specific genetic mutation called BRAF. BRAF is a human gene that makes a protein called B-raf. This protein is involved in sending signals to the cells which direct cell growth. BRAF tumor testing is common for this type of cancer. The performance of the test is not part of the research question in this study. If your tissue has a BRAF mutation, you will be eligible to participate in the next part of the study.
We expect that about 440 patients will get this screening for this study and expect that about 78 patients will go on to the treatment part of the study nationally. Approximately 4 patients will take part at The University of Arizona Cancer Center.
The purpose of the treatment part of the study is to compare any good and bad effects of using vemurafenib along with the usual chemotherapy approach alone. The addition of vemurafenib to the usual chemotherapy could shrink your cancer, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.
Study phase: II
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Adults, 18+ with histologically or cytologically documented adenocarcinoma of the colon or rectum that is either metastatic, or locally advanced and unresectable.
Primary disease category: Cancer
Protocol number: S1406
Projected enrollment dates: May 2015 to May 2017
Official study title: Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colon Cancer