Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00069108 |
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.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: capecitabine [Xeloda] Drug: Oxaliplatin Drug: Leucovorin Drug: 5 FU |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label Study of the Effect of Intermittent Xeloda Versus iv Fluorouracil/Leucovorin, Both in Combination With Eloxatin, on Tumor Progression in Patients With Metastatic Colorectal Cancer Who Received Prior CPT-11 and 5-Fluorouracil/Leucovorin |
Enrollment: | 627 |
Study Completion Date: | January 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: capecitabine [Xeloda]
1000mg/m2 po 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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | NO16967 |
Study First Received: | September 15, 2003 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00069108 |
Health Authority: | United States: Food and Drug Administration |
Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Disease Progression Leucovorin Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Vitamin B Complex Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Neoplasms Neoplasms by Site Vitamins Therapeutic Uses Micronutrients |