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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559741
• Other study ID #: CDR0000574065
• Secondary ID: CPP-FOLFIRICETUX
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: May 12, 2011
• Start date: October 2005

Study information

• Verified date: May 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• cetuximab

Drug:
• fluorouracil

• irinotecan hydrochloride

• leucovorin calcium

Other:
• pharmacological study

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers

Sponsors (1)

Lead Sponsor	Collaborator
ICO Paul Papin

Country where clinical trial is conducted

France, 

References & Publications (1)

Rouits E, Charasson V, Pétain A, Boisdron-Celle M, Delord JP, Fonck M, Laurand A, Poirier AL, Morel A, Chatelut E, Robert J, Gamelin E. Pharmacokinetic and pharmacogenetic determinants of the activity and toxicity of irinotecan in metastatic colorectal ca — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of hematologic and gastrointestinal tolerance to therapy			Yes
Secondary	Efficacy			No
Secondary	Genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of therapy			Yes
Secondary	Time to progression			No