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Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer

This study has been completed.
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC Identifier:
First received: March 7, 2000
Last updated: September 20, 2012
Last verified: September 2012

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether fluorouracil and leucovorin plus irinotecan is more effective than fluorouracil and leucovorin alone for colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have metastatic 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
Primary Purpose: Treatment
Official Title: CPT-11 in Combination With Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Relative to Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Alone in Patients With Advanced Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 430
Study Start Date: July 1999
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Compare the efficacy and toxicity of high-dose fluorouracil and leucovorin calcium with or without irinotecan in patients with metastatic adenocarcinoma of the colon or rectum. II. Compare progression-free survival, overall survival, response rate, and duration of response in patients treated with these 2 regimens. III. Compare quality of life of patients treated with these 2 regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. Arm II: Patients receive irinotecan IV over 30 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. Treatment in both arms repeats every 7 weeks in the absence of disease progression or unacceptable toxicity. Patients in arm I who develop disease progression begin second-line therapy comprising irinotecan, fluorouracil, and leucovorin calcium within 2 months of progression. Patients with complete response are taken off study after receiving treatment for one year. Quality of life is assessed before beginning study, after completion of each course, at 4 weeks after completion of study, and then every 2 months until disease progression or death. Patients are followed every 2 months until disease progression or death.

PROJECTED ACCRUAL: A total of 430 patients (215 per arm) will be accrued for this study within 2 years.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the colon or rectum Measurable or evaluable disease outside of any prior radiation port No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) (1.5 times ULN if liver metastasis present) AST and ALT no greater than 3 times ULN (5 times ULN if liver metastasis present) Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No severe cardiac disease No uncontrolled angina pectoris No myocardial infarction within the past 6 months Gastrointestinal: No unresolved bowel obstruction or subobstruction No uncontrolled Crohn's disease or ulcerative colitis No history of chronic diarrhea Other: No second malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer No other uncontrolled severe medical condition Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease No prior adjuvant chemotherapy containing topoisomerase I inhibitors At least 6 months since other prior adjuvant chemotherapy Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: See Disease Characteristics Surgery: Not specified Other: At least 4 weeks since other prior investigational drugs No other concurrent anticancer therapy

  Contacts and Locations
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Please refer to this study by its identifier: NCT00004885

  Hide Study Locations
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, A-1090
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
National Cancer Institute of Egypt
Cairo, Egypt
Institut Gustave Roussy
Villejuif, France, F-94805
PZB - Praxenzentrum
Aachen, Germany, D-52062
Kreiskrankenhaus Aurich
Aurich, Germany, D-26603
Braunschweig, Germany, D-38100
Humaine Klinik Dresden GmbH
Dresden, Germany, 01326
Medizinische Klinik I
Dresden, Germany, D-01307
Universitaetsklinik Duesseldorf
Duesseldorf, Germany, D-40225
St. Johannes Hospital - Medical Klinik II
Duisburg, Germany, D-47166
Emden, Germany, D-26721
Haemato-Onkol. Praxis
Essen, Germany, 45127
Kliniken Essen-Mitte
Essen, Germany, D-45136
Universitaetsklinik und Strahlenklinik - Essen
Essen, Germany, D-45122
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany, D-60590
Klinikum Frankfurt (Oder)
Frankfurt (Oder), Germany, D-15236
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, Germany, D-17487
Allgemeines Krankenhaus Hagen
Hagen, Germany, D-58095
Marien Hospital
Hagen, Germany, 58095
Internistisch - Onkologische Gemeinschaftspraxis
Halle, Germany, D-06110
Martin Luther Universitaet
Halle Saale, Germany, DOH-0-6112
Haematologisch-Onkologische Praxis Altona
Hamburg, Germany, D-22765
Hermann-Holthusen Institute for Radiotherapy
Hamburg, Germany, D-20099
Evangelische Krankenhaus Hamm
Hamm, Germany, DOH-5-9063
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Krankenhaus Siloah - Medizinische Klinik II
Hannover, Germany, D-30449
Henriettenstiftung - Chirurgische Klinik
Hannover, Germany, D-30171
Marienhospital/Ruhr University Bochum
Herne, Germany, DOH-4-4625
Universitatsklinik, Saarland
Homburg/Saar, Germany, D-66421
Haematologisch-Oncologische Praxis
Koblenz, Germany, D-56068
Klinikum Lippe-Lemgo
Lemgo, Germany, D-32657
Stift Bethlehem
Ludwigslust, Germany, D-19288
Otto-Von-Guericke-Universitaet Magdeburg
Magdeburg, Germany, D-39120
Staedtisches Klinikum Magdeburg
Magdeburg, Germany, D-39002
Johannes Gutenberg University
Mainz, Germany, D-55131
Muenchen Onkol. Praxis Elisenhof
Munich, Germany, D-80335
Kreiskrankenhaus Neustadt A. Rbge. des Landkreises Hannover
Neustadt, Germany, D-31533
Praxis Innere Medizin
Neustadt, Germany, D-01844
Klinikum Nurnberg
Nuremberg (Nurnberg), Germany, D-90419
Klinikum Ernst Von Bergmann
Postdam, Germany, D-14467
Klinikum D. Ch. Erxleben
Quedlinburg, Germany, D-06484
Kreiskrankenhaus Riesa
Riesa, Germany, D-01589
University of Rostock
Rostock, Germany, 18057
Fachkrankenhaus Marienstift
Schwarzenberg, Germany, D-08340
Stuttgart, Germany, D-70174
Eberhard Karls Universitaet
Tuebingen, Germany, D-72076
Klinikum der Universitaet Ulm
Ulm, Germany, D-89081
Harz-Klinikum Wernigerode GMBH - Medizinische Klinik
Wernigerode, Germany, D-38843
Klinikum der Stadt Wolfsburg
Wolfsburg, Germany, D-38440
Worms, Germany, DOH-6-7547
Medizinische Poliklinik, Universitaet Wuerzburg
Wuerzburg, Germany, D-97070
Witten University - Klinikum Wuppertal
Wuppertal, Germany, D-42283
Ospedale San Lazzaro
Alba, Italy, 12051
Saint Laurentius Ziekenhuis
Roermond, Netherlands, 6043 CV
Russian Federation
Russian Academy of Medical Sciences Cancer Research Center
Moscow, Russian Federation, 115478
South Africa
Medical Oncology Centre of Rosebank
Johannesburg, South Africa, 2193
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Claus-Henning Koehne, MD Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
  More Information

Additional Information:
Kohne CH, Van Custem E, Wils JA, et al.: Irinotecan improves the activity of the AIO regimen in metastatic colorectal cancer: results of EORTC GI Group study 40986. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1018, 2003.
Kohne C, van Cutsem E, Wils J, et al.: Weekly high dose infusional 5-FU plus folinic acid (FA) with or without irinotecan (IRI) in metastatic colorectal cancer (MCRC): interim safety results of EORTC study 40986. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-532, 2002.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00004885     History of Changes
Other Study ID Numbers: EORTC-40986, EORTC-40986
Study First Received: March 7, 2000
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on November 24, 2014