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

NCT00069121

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Colorectal Cancer

Interventions: Capecitabine, Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU)

Countries: United States, Australia, Belgium, Brazil, Canada, China, Finland, France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (232)
  • Mobile, Alabama, United States
  • Alhambra, California, United States
  • Bakersfield, California, United States
  • Fullerton, California, United States
  • Long Beach, California, United States
  • Northridge, California, United States
  • Oxnard, California, United States
  • Pomona, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Santa Barbara, California, United States
  • Vista, California, United States
  • Whittier, California, United States
  • Aurora, Colorado, United States
  • Fort Collins, Colorado, United States
  • Stamford, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Lakeland, Florida, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Peoria, Illinois, United States
  • Terre Haute, Indiana, United States
  • New Orleans, Louisiana, United States
  • Saint Louis Park, Minnesota, United States
  • Saint Joseph, Missouri, United States
  • St Louis, Missouri, United States
  • Billings, Montana, United States
  • Great Falls, Montana, United States
  • Reno, Nevada, United States
  • + 202 more on CT.gov