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Folfox-B Study for Patients With Colorectal Liver Metastases

NCT00508872 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2012-08-01

Study results available
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Summary

Objective:

* 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:

* 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:

* To evaluate the probability of complete response, partial response or stable disease.
* To evaluate the proportion of patients who are resected, and the proportion of patients achieving an R0 resection (among those receiving surgery).
* To correlate survival with downstaging and resection based on metastatic colorectal prognostic score.
* To evaluate the disease-free survival and overall survival.
* To evaluate the positron emission tomography response rate.
* To explore correlations of clinical response with telomerase and hTERT expression.

Conditions

  • Colorectal Liver Metastases

Interventions

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

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Eddie Abdalla, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00508872 on ClinicalTrials.gov