A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2005-06-01
Target enrollment:
Participant gender:
Summary
This is a Phase II, open label, non-randomized study in patients with histologically or
pathologically confirmed diagnosis of stage IIIB/IV, EGFR+ adenocarcinoma of the colon or
rectum who have not received prior chemotherapy for their metastatic disease.
Primary Study Endpoint:
To assess the response rate, progression-free survival, and overall safety profile of a
modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with
metastatic colorectal cancer.
Secondary Study Endpoint(s):
To assess overall survival of patients with metastatic colorectal cancer who receive
first-line therapy with a modified FOLFOX 6 + cetuximab regimen.