Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
NCT ID: NCT00004885
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
430 participants
INTERVENTIONAL
1999-07-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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FOLFIRI regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Claus-Henning Koehne, MD
Role: STUDY_CHAIR
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Locations
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Allgemeines Krankenhaus der Stadt Wien
Vienna, , Austria
U.Z. Gasthuisberg
Leuven, , Belgium
National Cancer Institute of Egypt
Cairo, , Egypt
Institut Gustave Roussy
Villejuif, , France
PZB - Praxenzentrum
Aachen, , Germany
Kreiskrankenhaus Aurich
Aurich, , Germany
Haematology-Oncology
Braunschweig, , Germany
Humaine Klinik Dresden GmbH
Dresden, , Germany
Medizinische Klinik I
Dresden, , Germany
St. Johannes Hospital - Medical Klinik II
Duisburg, , Germany
Universitaetsklinik Duesseldorf
Düsseldorf, , Germany
Hans-Susemihl-Krankenhaus
Emden, , Germany
Haemato-Onkol. Praxis
Essen, , Germany
Universitaetsklinik und Strahlenklinik - Essen
Essen, , Germany
Kliniken Essen-Mitte
Essen, , Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , Germany
Klinikum Frankfurt (Oder)
Frankfurt (Oder), , Germany
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, , Germany
Marien Hospital
Hagen, , Germany
Allgemeines Krankenhaus Hagen
Hagen, , Germany
Internistisch - Onkologische Gemeinschaftspraxis
Halle, , Germany
Martin Luther Universitaet
Halle, , Germany
Hermann-Holthusen Institute for Radiotherapy
Hamburg, , Germany
Haematologisch-Onkologische Praxis Altona
Hamburg, , Germany
Evangelische Krankenhaus Hamm
Hamm, , Germany
Henriettenstiftung - Chirurgische Klinik
Hanover, , Germany
Krankenhaus Siloah - Medizinische Klinik II
Hanover, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Marienhospital/Ruhr University Bochum
Herne, , Germany
Universitatsklinik, Saarland
Homburg/Saar, , Germany
Haematologisch-Oncologische Praxis
Koblenz, , Germany
Klinikum Lippe-Lemgo
Lemgo, , Germany
Stift Bethlehem
Ludwigslust, , Germany
Staedtisches Klinikum Magdeburg
Magdeburg, , Germany
Otto-Von-Guericke-Universitaet Magdeburg
Magdeburg, , Germany
Johannes Gutenberg University
Mainz, , Germany
Muenchen Onkol. Praxis Elisenhof
Munich, , Germany
Praxis Innere Medizin
Neustadt, , Germany
Kreiskrankenhaus Neustadt A. Rbge. des Landkreises Hannover
Neustadt, , Germany
Klinikum Nurnberg
Nuremberg (Nurnberg), , Germany
Klinikum Ernst Von Bergmann
Postdam, , Germany
Klinikum D. Ch. Erxleben
Quedlinburg, , Germany
Kreiskrankenhaus Riesa
Riesa, , Germany
University of Rostock
Rostock, , Germany
Fachkrankenhaus Marienstift
Schwarzenberg, , Germany
Katharinenhospital
Stuttgart, , Germany
Eberhard Karls Universitaet
Tübingen, , Germany
Klinikum der Universitaet Ulm
Ulm, , Germany
Harz-Klinikum Wernigerode GMBH - Medizinische Klinik
Wernigerode, , Germany
Klinikum der Stadt Wolfsburg
Wolfsburg, , Germany
Gemeinschaftspraxis
Worms, , Germany
Witten University - Klinikum Wuppertal
Wuppertal, , Germany
Medizinische Poliklinik, Universitaet Wuerzburg
Würzburg, , Germany
Ospedale San Lazzaro
Alba, , Italy
Saint Laurentius Ziekenhuis
Roermond, , Netherlands
Russian Academy of Medical Sciences Cancer Research Center
Moscow, , Russia
Medical Oncology Centre of Rosebank
Johannesburg, , South Africa
Countries
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References
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Kohne CH, van Cutsem E, Wils J, Bokemeyer C, El-Serafi M, Lutz MP, Lorenz M, Reichardt P, Ruckle-Lanz H, Frickhofen N, Fuchs R, Mergenthaler HG, Langenbuch T, Vanhoefer U, Rougier P, Voigtmann R, Muller L, Genicot B, Anak O, Nordlinger B; European Organisation for Research and Treatment of Cancer Gastrointestinal Group. Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986. J Clin Oncol. 2005 Aug 1;23(22):4856-65. doi: 10.1200/JCO.2005.05.546. Epub 2005 Jun 6.
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.
Other Identifiers
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EORTC-40986
Identifier Type: -
Identifier Source: secondary_id
EORTC-40986
Identifier Type: -
Identifier Source: org_study_id