An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination with Intravenous Oxaliplatin (Q3W) (“XELOX”) versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin with Intravenous Oxaliplatin (Q2W) (“FOLFOX4”) as Treatment for Patients with Metastatic Co

Primary objectives: To demonstrate that the combination of capecitabine plus oxaliplatin ("XELOX") is at least equivalent to the combination of 5-fluorouracil plus leucovorin plus oxaliplatin ("FOLFOX-4”) in terms of time to tumor progression or death (TTP) in patients with metastatic colorectal carcinoma who have received prior treatment with CPT-11 in combination with 5-FU as first line therapy.
Primary endpoints: At least equivalence with respect time to tumor progression or death (TTP).