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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Sanofi-Synthelabo |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00508872 |
Purpose
Objective:
Primary Objective:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Liver Metastases |
Drug: 5-Fluorouracil Drug: Bevacizumab Drug: Leucovorin Drug: Oxaliplatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Single-Institution Phase II Trial of Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab (Folfox-B) for Initially Unresectable Colorectal Liver Metastases: Downstaging Followed By Hepatic Resection |
| Enrollment: | 2 |
| Study Start Date: | November 2005 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: FOLFOX-B
FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
|
Drug: 5-Fluorouracil
400 mg/m^2 IV over 15 minutes, followed by 2400 mg/m^2 IV Over 46 Hours
Other Names:
Drug: Bevacizumab
5 mg/kg IV Over 30-90 Minutes On Day 1 Every 14 Days
Other Names:
Drug: Leucovorin
400 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
Other Names:
Drug: Oxaliplatin
85 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
Other Name: Eloxatin
|
Show Detailed Description
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| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Eddie Abdalla, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Eddie Abdalla, MD/Assistant Professor, U.T.M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00508872 History of Changes |
| Other Study ID Numbers: | 2004-0816 |
| Study First Received: | July 27, 2007 |
| Results First Received: | October 8, 2010 |
| Last Updated: | October 8, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Colorectal Liver Metastases Oxaliplatin Eloxatin Fluorouracil Leucovorin Bevacizumab |
Anti-VEGF monoclonal antibody rhuMAb-VEGF Folfox-B 5-FU Avastin |
|
Neoplasm Metastasis Neoplasms, Second Primary Liver Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Antibodies Antibodies, Monoclonal Fluorouracil Oxaliplatin Bevacizumab |
Leucovorin Levoleucovorin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Vitamin B Complex Vitamins Micronutrients Growth Substances |