A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

• Status: Completed
• Trial end date: 2011-04-21
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Fluorouracil; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed colon carcinoma, AJCC/UICC Stage III (Dukes stage C)

• Complete tumor resection; Patients operated with curative intent and with no macroscopic or microscopic evidence for remaining tumor who can be randomized to either treatment arm within 8 weeks after surgery. As this is an adjuvant trial patients should never have had any evidence of metastatic disease (including presence of tumor cells in the ascites).

• Have a life expectancy of at least 5 years

Exclusion Criteria:

• Pregnant or lactating women

• Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study

• Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated colon cancer

• Patients who have not completely recovered from surgery