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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00069095 |
Purpose
This 4 arm study will assess the efficacy and safety of oral Xeloda, or intravenous (iv) fluorouracil/leucovorin, in combination with iv Eloxatin (oxaliplatin) with or without iv Avastin as a first-line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin), in 3 week cycles, 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles), 3) XELOX + Avastin (7.5 mg iv on day 1)in 3 week cycles or 4)FOLFOX-4 + Avastin (5mg iv on day 1)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 Drug: Avastin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-label Study Comparing the Effect of First-line Treatment With Intermittent Xeloda Versus Fluorouracil/Leucovorin, Both in Combination With Eloxatin With or Without Avastin, on Tumor Progression in Patients With Metastatic Colorectal Cancer |
| Estimated Enrollment: | 2035 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | December 2009 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-15 of each 3 week cycle.
|
| 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.
|
| 3: Active Comparator |
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-15 of each 3 week cycle.
Drug: Oxaliplatin
As prescribed in 3 week cycles
Drug: Avastin
7.5mg iv on day 1 in each 3 week cycle
|
| 4: Active Comparator |
Drug: Leucovorin
As prescribed, in 2 week cycles
Drug: 5 FU
As prescribed, in 2 week cycles.
Drug: Avastin
5mg iv on day 1 of each 2 week cycle
|
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 236 Study Locations| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche ( Disclosures Group ) |
| Study ID Numbers: | NO16966 |
| Study First Received: | September 15, 2003 |
| Last Updated: | October 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00069095 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Bevacizumab Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses Growth Inhibitors |
Angiogenesis Modulating Agents Micronutrients Capecitabine Digestive System Neoplasms Vitamin B Complex Growth Substances Intestinal Diseases Angiogenesis Inhibitors Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |
