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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Sanofi-Synthelabo |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00508872 |
Purpose
Objective:
1. To evaluate the efficacy of the use of the combination of oxaliplatin, 5-fluorouracil, leucovorin and bevacizumab (FOLFOX-B) in patients with unresectable colorectal liver metastases, with the objective to downstage hepatic disease and enable complete resection of residual disease.
Primary Objective:
1. To evaluate the resection rate in patients with initially unresectable hepatic colorectal metastases downstaged with FOLFOX-B. Complete resection of all liver lesions is the goal.
Secondary Objectives:
| Condition | Intervention | Phase |
|
Colorectal Liver Metastases |
Drug: 5-Fluorouracil Drug: Bevacizumab Drug: Leucovorin Drug: Oxaliplatin |
Phase II |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Bevacizumab Fluorouracil Oxaliplatin |
| 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 |
| Estimated Enrollment: | 42 |
| Study Start Date: | November 2005 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Folfox-B
|
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
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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 | |||||
| M.D. Anderson Cancer Center |
| Sanofi-Synthelabo |
| 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 |
| First Received: | July 27, 2007 |
| Last Updated: | January 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00508872 |
| Health Authority: | United States: Institutional Review Board |
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