A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX-4") With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer

Trial Information

A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX-4") With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer

This study was conducted in 2 parts: An initial 2-arm part in which patients were randomized
to 1 of 2 different treatment groups (XELOX or FOLFOX-4), and a subsequent 2 x 2 factorial
part, added to the study through a protocol amendment, in which additional patients were
randomized into one of 4 different treatment groups (XELOX + placebo, FOLFOX-4 + placebo,
XELOX + bevacizumab, or FOLFOX-4 + bevacizumab). Due to the comparison of the oral agent
capecitabine with bolus and infused fluorouracil, the study was not blinded with respect to
these 2 treatments. The study was double-blind with regard to the administration of
bevacizumab, ie, there was a placebo control for bevacizumab in the second part of the
study.

The study consisted of 3 phases, a Primary Study Treatment Phase, a Post-Study Treatment
Phase, and a Follow-Up Phase.

Primary Study Treatment Phase

Patients were to receive up to 16 cycles (2-arm part of the study) or 24 cycles (4-arm part
of the study) of treatment during the Primary Study Treatment Phase (48 weeks).

Post-Study Treatment Phase

Patients who completed the 48-week primary study treatment phase without progressive disease
were eligible to enter the post-study treatment phase at the discretion of the investigator
and the sponsor. Patients who entered this phase were to continue treatment on the same
regimen to which they were initially randomized until either progression of disease was
documented, unacceptable toxicity occurred, or the patient withdrew consent.

Follow-up Phase

Patients who terminated study treatment during the primary or post-study treatment phase
were followed until disease progression or death.