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

Sponsor

Institut Cancerologie de l'Ouest (Other)

Overall Status

Completed

CT.gov ID

NCT00559741

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Biological: cetuximab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Other: pharmacological study	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

Improvement of hematologic and gastrointestinal tolerance to therapy []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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