Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2000 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on July 5, 2000. Last Updated on February 3, 2009 History of Changes

Sponsor:	Federation Nationale des Centres de Lutte Contre le Cancer
Collaborator:	Federation Francophone de Cancerologie Digestive
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005979

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer.

Condition	Intervention	Phase
Colorectal Cancer	Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Irinotecan U 101440E Irinotecan hydrochloride Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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

Study Start Date:

February 1998

Detailed Description:

OBJECTIVES:

Compare the effect of leucovorin calcium and fluorouracil with or without irinotecan on the 3 year survival rate and overall survival of patients with resected node positive colon cancer at high risk of recurrence.
Compare toxicities of these regimens in these patients.
Compare quality of life of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, disease type (occlusion vs perforation vs N2 only), delay between surgery and chemotherapy (28 days or less vs over 28 days), and age (under 65 vs 65 and over). Patients are randomized to one of two treatment arms.

Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2.
Arm II: Patients receive irinotecan IV over 90 minutes on day 1 followed by leucovorin calcium and fluorouracil as in arm I.

Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before treatment, after 6 and 12 courses, and then at 1 year.

Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven stage III adenocarcinoma of the colon that has been curatively resected within past 42 days
No metastatic disease
Node positive
- No more than 4 nodes affected (Tx, N2, M0) AND/OR
- N1 or N2 with perforation and/or occlusion
No prior rectal cancer within 10 cm of anal margin or that was treated with preoperative radiotherapy
No prior inflammatory disease of the intestine

PATIENT CHARACTERISTICS:

Age:

18 to 75

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Neutrophil count at least 2,000/mm3
Platelet count at least 100,000/mm3

Hepatic:

Bilirubin less than 1.25 times upper limit of normal (ULN)
SGOT and SGPT less than 3 times ULN
Alkaline phosphatase less than 3 times ULN

Renal:

Not specified

Cardiovascular:

No myocardial infarction within past 6 months
No insufficient cardiac function

Other:

No other serious medical illness
No active infection
No other malignancy except skin cancer or carcinoma in situ of the cervix
No psychological or social condition that would preclude study
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics

Surgery:

See Disease Characteristics
No prior extensive intestinal resection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005979

Locations

France
Centre Paul Papin
Angers, France, 49036
Clinique St. Etienne
Bayonne, France, 64100
Institut Bergonie
Bordeaux, France, 33076
Centre Hospitalier de Fleyriat
Bourg-En-Bresse, France, 01012
Centre Hospitalier de Bourgoin - Jallieu
Bourgoin-Jallieu, France, 38300
Centre Hospitalier General
Brive, France, 19101
Centre Regional Francois Baclesse
Caen, France, 14076
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94010
Faculte de Medecine
Dijon, France, 21033
Hopital Du Bocage
Dijon, France, 21034
Centre Hospitalier Maie Madeleine
Forbach, France, 57600
Centre Leon Berard
Lyon, France, 69008
Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
CHR D'Orleans - Hopital de la Source
Orleans, France, 45067
Institut Jean Godinot
Reims, France, 51056
St Joseph's Medical Center
Reims, France, 51056
Centre Hospitalier Universitaire
Reims, France, 51092
Centre Eugene Marquis
Rennes, France, 35064
Hopital Charles Nicolle
Rouen, France, 76031
Centre Rene Huguenin
Saint Cloud, France, 92210
Hopitaux Universitaire de Strasbourg
Strasbourg, France, 67091
Centre Hospitalier de Tarbes
Tarbes, France, 65013
Institut Claudius Regaud
Toulouse, France, 31052
Centre Hospitalier Valence
Valence, France, 26000
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Centre Hospitalier P. Chubert
Vannes, France, 56260
Centre Hospitalier Regionale de Vichy
Vichy, France, 03201
Institut Gustave Roussy
Villejuif, France, F-94805

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Federation Francophone de Cancerologie Digestive

Investigators

Study Chair:	Marc Ychou, MD, PhD	Centre Val d'Aurelle - Paul Lamarque
Study Chair:	Jean Faivre	Federation Francophone de Cancerologie Digestive

More Information

Additional Information:

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

Publications:

Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, Viret F, Becouarn Y, Bouché O, Gamelin E, Ducreux M, Conroy T, Seitz JF, Bedenne L, Kramar A. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009 Jan 29; [Epub ahead of print]

Cote JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, Thirouard AS, Selves J, Laurent-Puig P, Ychou M. UGT1A1 Polymorphism Can Predict Hematologic Toxicity in Patients Treated with Irinotecan. Clin Cancer Res. 2007 May 17; [Epub ahead of print]

ClinicalTrials.gov Identifier:	NCT00005979 History of Changes
Other Study ID Numbers:	CDR0000067967, FRE-FNCLCC-ACCORD-2, FFCD-9802, EU-20014
Study First Received:	July 5, 2000
Last Updated:	February 3, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III colon cancer
adenocarcinoma of the colon

Additional relevant MeSH terms:

Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Irinotecan
Camptothecin

Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012