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| Sponsored by: |
Hoffmann-La Roche |
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00069121 |
Purpose
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.
| Condition | Intervention | Phase |
|
Colorectal Cancer |
Drug: capecitabine [Xeloda] Drug: Oxaliplatin Drug: Leucovorin Drug: 5 FU |
Phase III |
| MedlinePlus related topics: | Cancer Colorectal Cancer |
| ChemIDplus related topics: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Capecitabine Fluorouracil Oxaliplatin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-Label Study of the Effect of Intermittent Xeloda in Combination With Eloxatin, Versus Fluorouracil/Leucovorin, on Disease-Free Survival in Patients Who Have Undergone Surgery for Colon Cancer.2 |
| Estimated Enrollment: | 1886 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | December 2008 |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: capecitabine [Xeloda]
1000mg/m2 iv bid on days 1-15 of each 3 week cycle
Drug: Oxaliplatin
As prescribed, in 3 week cycles
|
| 2: Active Comparator |
Drug: Oxaliplatin
As prescribed, in 2 week cycles
Drug: Leucovorin
As prescribed, in 2 week cycles.
Drug: 5 FU
As prescribed, in 2 week cycles
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations |
Show 228 Study Locations |
| Hoffmann-La Roche |
| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | NO16968 |
| First Received: | September 15, 2003 |
| Last Updated: | August 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00069121 |
| Health Authority: | United States: Food and Drug Administration |
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