|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
|---|---|
|
1: Experimental
FOLFOX-B: 5-Fluorouracil + Bevacizumab + Leucovorin + Oxaliplatin
|
Drug: 5-Fluorouracil
400 mg/m^2 IV Over 15 Minutes, followed by 2400 mg/m^2 IV Over 46 Hours
Drug: Bevacizumab
5 mg/kg IV Over 30-90 Minutes On Day 1 Every 14 Days
Drug: Leucovorin
400 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
Drug: Oxaliplatin
85 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
|
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 | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Eddie Abdalla, MD/Assistant Professor ) |
| Study ID Numbers: | 2004-0816 |
| Study First Received: | July 27, 2007 |
| Last Updated: | August 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00508872 History of Changes |
| 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 |
|
Antimetabolites Liver Diseases Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leucovorin Bevacizumab Antibodies, Monoclonal Liver Neoplasms Oxaliplatin Neoplastic Processes Neoplasms by Site Pathologic Processes |
Therapeutic Uses Vitamins Neoplasm Metastasis Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Digestive System Neoplasms Vitamin B Complex Growth Substances Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil |