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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00941499
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancers

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • HAI Oxaliplatin — DRUG
    140 mg/m\^2 by HAI (hepatic arterial infusion)over 2 hours on Day 1 of each 21 day cycle
  • 5-FU — DRUG
    900-1750 mg/m\^2 HAI infusion over 24 hours on Days 1 - 2 of each 21 day cycle.
  • Bevacizumab — DRUG
    10 mg/Kg by vein on Day 1 of 21 day cycle.
  • Cetuximab — DRUG
    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.
  • Leucovorin — DRUG
    200 mg/m\^2 by vein on Days 1 and 2 of each 21 day cycle.
  • 5-FU — DRUG
    300-400 mg/m\^2 bolus + 600-1000 mg/m\^2 infusion over 22 hours on Days 1-2 of each cycle.
  • Bevacizumab — DRUG
    7.5 - 15 mg/Kg by vein on Day 1 of 21 day cycle.

Study Details

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.

Key Dates

First listed
Jul 17, 2009
Start date
Jul 31, 2009
Status verified
Nov 2015
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

Enrollment
140 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    HAI oxaliplatin in combination with HAI 5-fluorouracil and IV bevacizumab
  • Experimental: Group 2
    HAI oxaliplatin in combination with IV 5-fluorouracil, leucovorin, bevacizumab, and cetuximab
  • Experimental: Group 3
    HAI oxaliplatin in combination with IV bevacizumab.
  • Experimental: Group 4
    HAI oxaliplatin in combination with IV bevacizumab and cetuximab.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of Intra-Arterial Hepatic Oxaliplatin [ Time Frame: 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
UT MD Anderson Cancer Center· Houston, TX

Related Studies