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Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00026273
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):

Brief 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 and giving them after surgery may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Phase 3

Detailed Description:


  • Compare the disease-free survival at 3 years of patients with resected stage III colorectal cancer treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan.
  • Compare the disease-free and overall survival at 5 years of patients treated with these regimens.
  • Compare the safety profiles of these treatment regimens in these patients.
  • Compare the quality-adjusted survival of patients treated with these regimens.
  • Correlate the expression of putative prognostic markers (thymidylate synthase, telomerase, topoisomerase) with disease-free and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I

  • Patients receive irinotecan IV over 30-90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 24 hours weekly for 6 weeks. Courses repeat every 7 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • As an alternative schedule, patients may receive irinotecan IV over 30-90 minutes and day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2 every 2 weeks for 6 weeks. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Arm II

  • Patients receive leucovorin calcium and fluorouracil as in arm I. Quality of life may be assessed at baseline; prior to courses 2, 3, and 4; and at 1, 3, and 6 months.

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

PROJECTED ACCRUAL: Approximately 1800 patients (900 per arm) will be accrued for this study within 24 months.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone As Adjuvant Treatment Of Stage III Colon Cancer
Study Start Date : January 2001
Actual Primary Completion Date : September 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the colon or intraperitoneal rectum

    • Stage III
    • Completely resected within the past 3-8 weeks

      • No gross or microscopic evidence of residual disease after surgery
  • No rectal cancer requiring total meso-rectal resection or pre- or postoperative radiotherapy
  • No prior curatively resected synchronous metastasis of colorectal cancer



  • 18 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 150,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • No myocardial infarction with the past year
  • No uncontrolled hypertension
  • No high-risk uncontrolled arrhythmia
  • No unstable angina pectoris


  • HIV negative
  • No chronic diarrhea
  • No current chronic inflammation or subobstruction of bowel after surgery
  • No active uncontrolled infection
  • No other prior or concurrent malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No psychological, social, familial, or geographical condition that would preclude follow-up
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation


Biologic therapy:

  • Not specified


  • No prior antineoplastic chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • See Disease Characteristics
  • No prior celioscopic resection of primary tumor


  • At least 30 days since prior participation in another clinical trial with any investigational drug
  • No other concurrent experimental drugs
  • No other concurrent anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026273

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Allgemeines Krankenhaus der Stadt Wien
Vienna (Wien), Austria, A-1090
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
National Cancer Institute of Egypt
Cairo, Egypt
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Tenon
Paris, France, 75970
Universitats-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
Universita Degli Studi di Firenze - Policlin. di Careggi
Firenze (Florence), Italy, 1 (50-134)
Ospedale San Carlo Borromeo
Milano (Milan), Italy, 20153
Azienda Ospedaliera S. Maria
Terni, Italy, 05100
Universita Degli Studi di Udine
Udine, Italy, 33100
Instituto Portugues de Oncologia do Porto
Porto, Portugal, 4200
Hospital Universarito "Reina Sofia"
Cordoba, Spain, 14004
Hopital Cantonal Universitaire de Geneva
Geneva, Switzerland, CH-1211
United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
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Study Chair: Eric Van Cutsem, MD, PhD University Hospital, Gasthuisberg
Publications of Results:
Roth AD, Tejpar S, Yan P, et al.: Correlation of molecular markers in colon cancer with stage-specific prognosis: results of the translational study on the PETACC 3 - EORTC 40993-SAKK 60-00 trial. [Abstract] American Society of Clinical Oncology 2009 Gastrointestinal Cancers Symposium, 15-17 January 2009, San Francisco, CA. A-288, 2009.
Tejpar S, Bosman F, Delorenzi M, et al.: Microsatellite instability (MSI) in stage II and III colon cancer treated with 5FU-LV or 5FU-LV and irinotecan (PETACC 3-EORTC 40993-SAKK 60/00 trial). [Abstract] J Clin Oncol 27 (Suppl 15): A-4001, 2009.
Roth AD, Yan P, Dietrich D, et al.: Does UGT1A1*28 homozygosity predict for severe toxicity in patients treated with 5-fluorouracil (5-FU)-irinotecan (IRI)? Results of the PETACC 3-EORTC 40993-SAKK 60/00 trial comparing IRI/5-FU/folinic acid (FA) to 5-FU/FA in stage II-III colon cancer. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-277, 2008.
Roth AD, Yan P, Dietrich D, et al.: Is UGT1A1*28 homozygosity the strongest predictor for severe hematotoxicity in patients treated with 5-fluorouracil (5-FU)-irinotecan (IRI)? Results of the PETACC 3 - EORTC 40993 -SAKK 60/00 trial comparing IRI/5-FU/folinic acid (FA) to 5-FU/FA in stage II- III colon cancer (COC) patients. [Abstract] J Clin Oncol 26 (Suppl 15): A-4036, 2008.
van Cutsem E, Labianca R, Hossfeld D, et al.: Randomized phase III trial comparing infused irinotecan / 5-fluorouracil (5-FU)/folinic acid (IF) versus 5-FU/FA (F) in stage III colon cancer patients (pts). (PETACC 3). [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA8, 3s, 2005.

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00026273    
Other Study ID Numbers: XRP 4174B-307
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012
Keywords provided by Pfizer:
stage III colon cancer
stage III rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protective Agents
Vitamin B Complex