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	Treatment or Intervention	Phase
stage III colon cancer adenocarcinoma of the colon	Drug: fluorouracil  Drug: irinotecan  Drug: leucovorin calcium  Procedure: chemotherapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Marc Ychou, MD,  Study Chair,  Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle   
Jean Faivre,  Study Chair,  Faculte de Medecine   

Study ID Numbers:  CDR0000067967; FRE-FNCLCC-ACCORD-2; FFCD-9802; EU-20014
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005979
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08