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

NCT00980239 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2015-11-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Irinotecan

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).

DRUG

Bevacizumab

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.

DRUG

Oxaliplatin

Starting dose 60 mg/m\^2 by vein over 2 hours on Days 1 and 15 of every cycle.

DRUG

Cetuximab

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Apostolia M. Tsimberidou, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00980239 on ClinicalTrials.gov