Folfox-B Study for Patients With Colorectal Liver Metastases

Conditions

• Colorectal Liver Metastases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 5-Fluorouracil — DRUG
  400 mg/m\^2 IV over 15 minutes, followed by 2400 mg/m\^2 IV Over 46 Hours
• Bevacizumab — DRUG
  5 mg/kg IV Over 30-90 Minutes On Day 1 Every 14 Days
• Leucovorin — DRUG
  400 mg/m\^2 IV Over 2 Hours On Day 1 Every 14 Days
• Oxaliplatin — DRUG
  85 mg/m\^2 IV Over 2 Hours On Day 1 Every 14 Days

Study Details

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.

Key Dates

First listed

Jul 30, 2007

Start date

Nov 30, 2005

Status verified

Jul 2012

Primary completion

Jun 30, 2009

Completion

Jun 30, 2009

Study Design

Enrollment

2 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Complete Gross Resection Rate [ Time Frame: Over 4 year study period ]

Locations (1)

Find similar trials in Houston, TX

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• Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)
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