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

Phase 3

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00004885
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

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.

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.

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 2000-03-07
• Primary Completion: 2001-07
• Study First Submitted QC: 2004-04-09
• Study First Posted: 2004-04-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (57)

National Cancer Institute of Egypt; 🇪🇬 Cairo, Egypt

St. Johannes Hospital - Medical Klinik II; 🇩🇪 Duisburg, Germany

Universitaetsklinik und Strahlenklinik - Essen; 🇩🇪 Essen, Germany

Medizinische Klinik I; 🇩🇪 Dresden, Germany

PZB - Praxenzentrum; 🇩🇪 Aachen, Germany

Humaine Klinik Dresden GmbH; 🇩🇪 Dresden, Germany

Hans-Susemihl-Krankenhaus; 🇩🇪 Emden, Germany

Kliniken Essen-Mitte; 🇩🇪 Essen, Germany

Internistisch - Onkologische Gemeinschaftspraxis; 🇩🇪 Halle, Germany

Henriettenstiftung - Chirurgische Klinik; 🇩🇪 Hannover, Germany

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Haematology-Oncology; 🇩🇪 Braunschweig, Germany

Kreiskrankenhaus Aurich; 🇩🇪 Aurich, Germany

Allgemeines Krankenhaus Hagen; 🇩🇪 Hagen, Germany

Haematologisch-Oncologische Praxis; 🇩🇪 Koblenz, Germany

Marienhospital/Ruhr University Bochum; 🇩🇪 Herne, Germany

Praxis Innere Medizin; 🇩🇪 Neustadt, Germany

Stift Bethlehem; 🇩🇪 Ludwigslust, Germany

Johannes Gutenberg University; 🇩🇪 Mainz, Germany

Klinikum D. Ch. Erxleben; 🇩🇪 Quedlinburg, Germany

Kreiskrankenhaus Riesa; 🇩🇪 Riesa, Germany

Katharinenhospital; 🇩🇪 Stuttgart, Germany

Russian Academy of Medical Sciences Cancer Research Center; 🇷🇺 Moscow, Russian Federation

Saint Laurentius Ziekenhuis; 🇳🇱 Roermond, Netherlands

Ospedale San Lazzaro; 🇮🇹 Alba, Italy

Klinikum der Universitaet Ulm; 🇩🇪 Ulm, Germany

Medizinische Poliklinik, Universitaet Wuerzburg; 🇩🇪 Wuerzburg, Germany

Klinikum der Stadt Wolfsburg; 🇩🇪 Wolfsburg, Germany

Witten University - Klinikum Wuppertal; 🇩🇪 Wuppertal, Germany

Universitaetsklinik Duesseldorf; 🇩🇪 Duesseldorf, Germany

Haemato-Onkol. Praxis; 🇩🇪 Essen, Germany

Klinikum Frankfurt (Oder); 🇩🇪 Frankfurt (Oder), Germany

Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet; 🇩🇪 Greifswald, Germany

Marien Hospital; 🇩🇪 Hagen, Germany

Hermann-Holthusen Institute for Radiotherapy; 🇩🇪 Hamburg, Germany

Martin Luther Universitaet; 🇩🇪 Halle Saale, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Klinikum Ernst Von Bergmann; 🇩🇪 Postdam, Germany

Klinikum Lippe-Lemgo; 🇩🇪 Lemgo, Germany

Staedtisches Klinikum Magdeburg; 🇩🇪 Magdeburg, Germany

Otto-Von-Guericke-Universitaet Magdeburg; 🇩🇪 Magdeburg, Germany

Universitatsklinik, Saarland; 🇩🇪 Homburg/Saar, Germany

Kreiskrankenhaus Neustadt A. Rbge. des Landkreises Hannover; 🇩🇪 Neustadt, Germany

University of Rostock; 🇩🇪 Rostock, Germany

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Klinikum der J.W. Goethe Universitaet; 🇩🇪 Frankfurt, Germany

Fachkrankenhaus Marienstift; 🇩🇪 Schwarzenberg, Germany

Evangelische Krankenhaus Hamm; 🇩🇪 Hamm, Germany

Haematologisch-Onkologische Praxis Altona; 🇩🇪 Hamburg, Germany

Krankenhaus Siloah - Medizinische Klinik II; 🇩🇪 Hannover, Germany

Muenchen Onkol. Praxis Elisenhof; 🇩🇪 Munich, Germany

Klinikum Nurnberg; 🇩🇪 Nuremberg (Nurnberg), Germany

Eberhard Karls Universitaet; 🇩🇪 Tuebingen, Germany

Medical Oncology Centre of Rosebank; 🇿🇦 Johannesburg, South Africa

Harz-Klinikum Wernigerode GMBH - Medizinische Klinik; 🇩🇪 Wernigerode, Germany

Gemeinschaftspraxis; 🇩🇪 Worms, Germany

Allgemeines Krankenhaus der Stadt Wien; 🇦🇹 Vienna, Austria