Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00026273
First received: November 9, 2001
Last updated: August 6, 2012
Last verified: August 2012
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Purpose
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:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Levoleucovorin
Irinotecan
Irinotecan hydrochloride
U.S. FDA Resources
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) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026273
Locations
| Austria | |
| Allgemeines Krankenhaus der Stadt Wien | |
| Vienna (Wien), Austria, A-1090 | |
| Belgium | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Egypt | |
| National Cancer Institute of Egypt | |
| Cairo, Egypt | |
| France | |
| CHU Pitie-Salpetriere | |
| Paris, France, 75651 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Germany | |
| Universitats-Krankenhaus Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Italy | |
| 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 | |
| Portugal | |
| Instituto Portugues de Oncologia do Porto | |
| Porto, Portugal, 4200 | |
| Spain | |
| Hospital Universarito "Reina Sofia" | |
| Cordoba, Spain, 14004 | |
| Switzerland | |
| Hopital Cantonal Universitaire de Geneva | |
| Geneva, Switzerland, CH-1211 | |
| United Kingdom | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Chair: | Eric Van Cutsem, MD, PhD | U.Z. Gasthuisberg |
More Information
Additional Information:
Publications:
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, Popovici V, Delorenzi M, et al.: Mutant KRAS and BRAF gene expression profiles in colorectal cancer: results of the translational study on the PETACC 3-EORTC 40993-SAKK 60-00 trial. [Abstract] J Clin Oncol 28 (Suppl 15): A-3505, 2010.
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.
Roth AD, Tejpar S, Yan P, et al.: Stage-specific prognostic value of molecular markers in colon cancer: results of the translational study on the PETACC 3-EORTC 40993-SAKK 60-00 trial. [Abstract] J Clin Oncol 27 (Suppl 15): A-4002, 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.
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00026273 History of Changes |
| Other Study ID Numbers: | XRP 4174B-307, CDR0000069014, PFIZER-A5961053, RP-64174-V-307, EORTC-40993, PETACC-3 |
| Study First Received: | November 9, 2001 |
| Last Updated: | August 6, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Pfizer:
|
stage III colon cancer stage III rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Irinotecan Camptothecin |
Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013