|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 2035 |
| Study Start Date: | July 2003 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-15 of each 3 week cycle.
|
| Active Comparator: 2 |
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.
|
| Active Comparator: 3 |
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
|
| Active Comparator: 4 |
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 237 Study Locations| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00069095 History of Changes |
| Other Study ID Numbers: | NO16966 |
| Study First Received: | September 15, 2003 |
| Last Updated: | July 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Leucovorin Bevacizumab Levoleucovorin Oxaliplatin |
Capecitabine Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors |
