Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer

May 12, 2011 updated by: Institut Cancerologie de l'Ouest

Phase 2 Study to Improve Tolerance of Chemotherapy Involving Cetuximab and Multidrug FOLFIRI, With Pharmacokinetic and Pharmacogenetic Studies, in Patients With Metastatic Colorectal Cancer

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works in treating patients with advanced or metastatic colorectal cancer.

Study Overview

Status

Completed

Conditions

Colorectal Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

Improve hematologic and gastrointestinal tolerance to cetuximab and irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) in patients with advanced or metastatic colorectal cancer.

Secondary

Increase the effectiveness of this regimen by intensifying the treatment.
Specify the constitutional genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of this regimen.
Assess the time to progression.

OUTLINE: This is a multicenter study.

Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and cetuximab IV over 1-2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Pharmacokinetic and pharmacogenetic studies are also conducted.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Angers, France, 49036
    - Centre Paul Papin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Histologically confirmed colorectal cancer
- Advanced or metastatic disease
Scheduled to receive first- or second-line therapy for metastatic disease
No cerebral metastases or symptomatic or uncontrolled meningeal disease

PATIENT CHARACTERISTICS:

WHO performance status 0-2
ANC ≥ 2,000/mm^3
Platelet count ≥ 100,000/mm^3
Total bilirubin ≤ 2 times upper limit of normal (ULN)
AST and ALT ≤ 3 times ULN
Alkaline phosphatase ≤ 5 times ULN
Not pregnant or nursing
Fertile patients must use effective contraception
No intestinal blockage
No complete dihydropyrimidine dehydrogenase deficiency
No chronic inflammatory disease of the colon
No other cancer except for nonmelanoma skin cancer or curatively treated carcinoma of the cervix or breast
No other severe condition, or condition that is likely to worsen, including any of the following:
- Unstable heart disease
- Myocardial infarction within the past 6 months
- Active uncontrolled infection
No contraindication to atropine

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from prior anticancer therapy
More than 4 weeks since prior and no other concurrent investigational therapy
Prior adjuvant chemotherapy allowed
No prior fluorouracil or irinotecan hydrochloride
No other concurrent anticancer therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement of hematologic and gastrointestinal tolerance to therapy

Secondary Outcome Measures

Outcome Measure
Time to progression
Efficacy
Genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

Study Chair: Erick Gamelin, MD, Institut Cancerologie de l'Ouest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

May 13, 2011

Last Update Submitted That Met QC Criteria

May 12, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000574065
CPP-FOLFIRICETUX
INCA-RECF0108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.