Cetuximab and Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer - Full Text View

Sponsored by:	Centre Paul Papin
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00559741

Purpose

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	Intervention	Phase
Colorectal Cancer	Drug: cetuximab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Procedure: pharmacological study	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Fluorouracil Calcium gluconate Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Improvement of hematologic and gastrointestinal tolerance to therapy [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy [ Designated as safety issue: No ]
Genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of therapy [ Designated as safety issue: Yes ]
Time to progression [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	October 2005
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559741

Locations

France
Centre Paul Papin
Angers, France, 49036

Sponsors and Collaborators

Centre Paul Papin

Investigators

Study Chair:

Erick Gamelin, MD

Centre Paul Papin

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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 cancer patients. Br J Cancer. 2008 Oct 21;99(8):1239-45. Epub 2008 Sep 16.

Study ID Numbers:	CDR0000574065, CPP-FOLFIRICETUX, INCA-RECF0108
Study First Received:	November 15, 2007
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00559741
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV colon cancer
recurrent colon cancer
stage IV rectal cancer
recurrent rectal cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Cetuximab
Irinotecan
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Camptothecin

Recurrence
Intestinal Neoplasms
Rectal neoplasm
Calcium, Dietary
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009