HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00980239
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    Starting dose of 35 mg/m\^2 given through the catheter into your liver artery (hepatic artery infusion - HAI), continuously for 72 hours (Days 1 through 2 of each cycle).
  • Bevacizumab — DRUG
    10 mg/Kg by vein on Days 1 and 15 of every 28 day cycle, over 90 minutes first cycle and over 30-60 minutes subsequent cycles.
  • Oxaliplatin — DRUG
    Starting dose 60 mg/m\^2 by vein over 2 hours on Days 1 and 15 of every cycle.
  • Cetuximab — DRUG
    500 mg/m\^2 by vein on Days 1 and 15 of every cycle. The first time given over 2 hours, all other cycles over 1 hour.

Study Details

The goal of this clinical research study is to learn the highest tolerable dose of irinotecan that can be given directly into the liver, in combination with other drugs given by vein. The other drug combinations given by vein include bevacizumab alone, bevacizumab plus oxaliplatin, and bevacizumab plus cetuximab. This will be tested in patients with advanced solid tumors that have spread to the liver. The safety of these drug combinations will also be studied.

Key Dates

Start date
Sep 30, 2009
Status verified
Nov 2015
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015

Study Design

Enrollment
115 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Group 1 = Irinotecan + Bevacizumab
  • Experimental: Group 2
    Group 2 = Irinotecan, Bevacizumab + Oxaliplatin
  • Experimental: Group 3
    Group 3 = Irinotecan, Bevacizumab + Cetuximab

Primary Outcome Measure

Maximum Tolerated Doses (MTDs) [ Time Frame: Evaulated with each 28 day cycle ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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