A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

Completed · Phase 3

Conditions studied: Colorectal Cancer

In brief

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. 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) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Key facts

Study ID

NCT00069108

Run by

Hoffmann-La Roche

People needed

627

Starts

2003-07-01

Expected to finish

2006-08-01

Last updated by the study team

2016-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients >=18 years of age;
• metastatic colorectal cancer;
• >=1 target lesion;
• failed first-line chemotherapy with 5-fluorouracil and irinotecan.

You may not qualify if…

• previous treatment with oxaliplatin;
• progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;
• >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.

Where it is running

• Study site — Colorado Springs, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Terre Haute, Indiana, United States
• Study site — St Louis, Missouri, United States
• Study site — Billings, Montana, United States
• Study site — Nyack, New York, United States
• Study site — Dallas, Texas, United States
• Study site — Brussels, Belgium
• Study site — Brussels, Belgium
• Study site — Ghent, Belgium
• Study site — Kortrijk, Belgium
• Study site — Mont-godinne, Belgium
• Study site — Edmonton, Alberta, Canada
• Study site — St. John's, Newfoundland and Labrador, Canada
• Study site — Halifax, Nova Scotia, Canada
• Study site — London, Ontario, Canada
• Study site — Oshawa, Ontario, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Saint Catherines, Ontario, Canada
• Study site — Thunder Bay, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Weston, Ontario, Canada
• Study site — Laval, Quebec, Canada
• Study site — Lévis, Quebec, Canada
• Study site — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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