Back to resultsFluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FOLFIRI regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage III rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 150,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: 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 Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction with the past year No uncontrolled hypertension No high-risk uncontrolled arrhythmia No unstable angina pectoris Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior antineoplastic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics No prior celioscopic resection of primary tumor Other: 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
Sites / Locations
- Allgemeines Krankenhaus der Stadt Wien
- U.Z. Gasthuisberg
- National Cancer Institute of Egypt
- CHU Pitie-Salpetriere
- Hopital Tenon
- Universitats-Krankenhaus Eppendorf
- Ospedali Riuniti di Bergamo
- Universita Degli Studi di Firenze - Policlin. di Careggi
- Ospedale San Carlo Borromeo
- Azienda Ospedaliera S. Maria
- Universita Degli Studi di Udine
- Instituto Portugues de Oncologia do Porto
- Hospital Universarito "Reina Sofia"
- Hopital Cantonal Universitaire de Geneva
- Royal Marsden Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00026273
Brief Title
Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
Detailed Description
OBJECTIVES:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage III colon cancer, stage III rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age:
18 to 75
Performance status:
WHO 0-1
Life expectancy:
Not specified
Hematopoietic:
Absolute neutrophil count at least 2,000/mm^3
Platelet count at least 150,000/mm^3
Hemoglobin at least 10 g/dL
Hepatic:
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
Renal:
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min
Cardiovascular:
No myocardial infarction with the past year
No uncontrolled hypertension
No high-risk uncontrolled arrhythmia
No unstable angina pectoris
Other:
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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
No prior antineoplastic chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
See Disease Characteristics
Surgery:
See Disease Characteristics
No prior celioscopic resection of primary tumor
Other:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Van Cutsem, MD, PhD
Organizational Affiliation
University Hospital, Gasthuisberg
Official's Role
Study Chair
Facility Information:
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Vienna (Wien)
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
National Cancer Institute of Egypt
City
Cairo
Country
Egypt
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Universitats-Krankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Universita Degli Studi di Firenze - Policlin. di Careggi
City
Firenze (Florence)
ZIP/Postal Code
1 (50-134)
Country
Italy
Facility Name
Ospedale San Carlo Borromeo
City
Milano (Milan)
ZIP/Postal Code
20153
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Universita Degli Studi di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Instituto Portugues de Oncologia do Porto
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Hospital Universarito "Reina Sofia"
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hopital Cantonal Universitaire de Geneva
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
17596575
Citation
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Results Reference
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PubMed Identifier
20008640
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Citation
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PubMed Identifier
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Citation
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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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