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Hepatic Arterial Infusion Oxaliplatin + 5FU, Leucovorin, and Bevacizumab +/- Cetuximab

NCT00941499 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2015-11-18

No results posted yet for this study

Summary

The goal of this clinical research study is to find the best combination of oxaliplatin, bevacizumab, 5-fluorouracil, leucovorin, and cetuximab that can be given to patients with advanced cancer that has spread to the liver. Different combinations of these drugs will be used, and the safety of all drug combinations will also be studied.

Conditions

Interventions

DRUG

HAI Oxaliplatin

140 mg/m\^2 by HAI (hepatic arterial infusion)over 2 hours on Day 1 of each 21 day cycle

DRUG

5-FU

900-1750 mg/m\^2 HAI infusion over 24 hours on Days 1 - 2 of each 21 day cycle.

DRUG

Bevacizumab

10 mg/Kg by vein on Day 1 of 21 day cycle.

DRUG

Cetuximab

Loading dose of 250-500mg/m\^2 and Maintenance dose of 125-250 mg/m\^2 by vein on Day 1 of 21 day cycle.

DRUG

Leucovorin

200 mg/m\^2 by vein on Days 1 and 2 of each 21 day cycle.

DRUG

5-FU

300-400 mg/m\^2 bolus + 600-1000 mg/m\^2 infusion over 22 hours on Days 1-2 of each cycle.

DRUG

Bevacizumab

7.5 - 15 mg/Kg by vein on Day 1 of 21 day cycle.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Apostolia M. Tsimberidou, MD, PHD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00941499 on ClinicalTrials.gov