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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: November 9, 2001
Last updated: August 6, 2012
Last verified: August 2012

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 Intervention Phase
Colorectal Cancer
Drug: FOLFIRI regimen
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Study Start Date: January 2001
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00026273

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
Study Chair: Eric Van Cutsem, MD, PhD University Hospital, Gasthuisberg
  More Information

Delorenzi M, Budinska E, Popovici V, et al.: Molecular classes in CRC: characterization of MSI by expression profiling in the translational study of the PETACC 3-EORTC 40993- SAKK 60-00 trial. [Abstract] J Clin Oncol 28 (Suppl 15): A-3597, 2010.
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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT00026273     History of Changes
Other Study ID Numbers: XRP 4174B-307
Study First Received: November 9, 2001
Last Updated: August 6, 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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protective Agents processed this record on April 27, 2017