A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
Completed · Phase 3
Conditions studied: Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT00069121
- Run by
- Hoffmann-La Roche
- People needed
- 1886
- Starts
- 2003-04-18
- Expected to finish
- 2011-04-21
- Last updated by the study team
- 2020-03-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Central Hematology Oncology Medical Group Inc. — Alhambra, California, United States
- Comprehensive Blood/Cancer Ctr — Bakersfield, California, United States
- Virginia K. Crossen Cancer Center — Fullerton, California, United States
- Pacific Shores Medical Group — Long Beach, California, United States
- West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center — Northridge, California, United States
- Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
- Wilshire Oncology Medical Group — Pomona, California, United States
- Sutter Cancer Center — Sacramento, California, United States
- Scripps Cancer Center — San Diego, California, United States
- Kaiser Permanente San Diego; Hepatology Research — San Diego, California, United States
- Santa Barbara Hematology Oncology Medical Group, Inc. — Santa Barbara, California, United States
- San Diego Cancer Center'S Medical Group — Vista, California, United States
- Innovative clinical research institute/American institute of research — Whittier, California, United States
- University of Colorado Health Science Center; Biomedical Research Bldg. Room 511 — Aurora, Colorado, United States
- Hematology Oncology Associates — Fort Collins, Colorado, United States
- Hematology Oncology P.C. — Stamford, Connecticut, United States
- Georgetown Uni Medical Center; Lombardi Cancer Center — Washington D.C., District of Columbia, United States
- Lakeland Regional Cancer Center — Lakeland, Florida, United States
- Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center — Miami, Florida, United States
- Georgia Cancer Specialists — Atlanta, Georgia, United States
- Illinois Cancer Care — Peoria, Illinois, United States
- Hope Center — Terre Haute, Indiana, United States
- Ochsner Cancer Inst. — New Orleans, Louisiana, United States
- Park Nicollet Clinic Cancer Center — Saint Louis Park, Minnesota, United States
- The Cancer Center At Providence Park — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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