Genentech to Continue Phase III Colon Cancer Study
Genentech, a biotechnology company, has announced that it has been informed by the National Surgical Adjuvant Breast and Bowel Project that an ongoing Phase III study of Avastin plus chemotherapy in patients with early-stage colon cancer will continue as planned.
The National Surgical Adjuvant Breast and Bowel Project’s (NSABP) decision to continue the trial was based on a recommendation from an independent data monitoring committee (DMC) after a planned interim analysis.
The study of 2,710 patients is being conducted by the NSABP and is sponsored by the National Cancer Institute. The independent DMC is responsible for monitoring patient safety and efficacy, as well as recommending whether to stop or continue the trial. Genentech anticipates final results from NSABP C-08 in mid-2009.
NSABP C-08 is a randomized, multi-center Phase III study designed to evaluate the effect of Folfox chemotherapy with or without Avastin on disease-free survival in patients with resected stage II or III adenocarcinoma of the colon.
The trial is being conducted primarily in the US. Patients enrolled in the two-arm study were randomized after surgery to receive either Folfox alone for six months or Avastin in combination with Folfox for six months followed by an additional six months of Avastin monotherapy. Overall survival is a secondary endpoint of the study.