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

Colorectal Cancer Clinical Trial

Official title:

Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005979
• Other study ID #: CDR0000067967
• Secondary ID: FRE-FNCLCC-ACCOR
• Status: Completed
• Phase: Phase 3
• Start date: July 22, 1998
• Est. completion date: September 1, 2007

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 1, 2007
• Est. primary completion date: September 26, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer

Intervention

Drug:
• FOLFIRI regimen

• fluorouracil

• irinotecan hydrochloride

• leucovorin calcium

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Clinique St. Etienne	Bayonne
France	Institut Bergonie	Bordeaux
France	Centre Hospitalier de Fleyriat	Bourg-En-Bresse
France	Centre Hospitalier de Bourgoin - Jallieu	Bourgoin-Jallieu
France	Centre Hospitalier General	Brive
France	Centre Regional Francois Baclesse	Caen
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Faculte de Medecine	Dijon
France	Hopital Du Bocage	Dijon
France	Centre Hospitalier Maie Madeleine	Forbach
France	Centre Leon Berard	Lyon
France	Institut J. Paoli and I. Calmettes	Marseille
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	CHR D'Orleans - Hopital de la Source	Orleans
France	Centre Hospitalier Universitaire	Reims
France	Institut Jean Godinot	Reims
France	St Joseph's Medical Center	Reims
France	Centre Eugene Marquis	Rennes
France	Hopital Charles Nicolle	Rouen
France	Centre Rene Huguenin	Saint Cloud
France	Hopitaux Universitaire de Strasbourg	Strasbourg
France	Centre Hospitalier de Tarbes	Tarbes
France	Institut Claudius Regaud	Toulouse
France	Centre Hospitalier Valence	Valence
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Centre Hospitalier P. Chubert	Vannes
France	Centre Hospitalier Regionale de Vichy	Vichy
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
UNICANCER	Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

References & Publications (2)

Côté 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 Jun 1;13(11):3269-75. Epub 2 — View Citation

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- — View Citation