Spots Global Cancer Trial Database for Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
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
Study ID: NCT00004885
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Universitaetsklinik Duesseldorf, Duesseldorf, , Germany
St. Johannes Hospital - Medical Klinik II, Duisburg, , Germany
Hans-Susemihl-Krankenhaus, Emden, , Germany
Haemato-Onkol. Praxis, Essen, , Germany
Universitaetsklinik und Strahlenklinik - Essen, Essen, , Germany
Kliniken Essen-Mitte, Essen, , Germany
Klinikum Frankfurt (Oder), Frankfurt (Oder), , Germany
Klinikum der J.W. Goethe Universitaet, Frankfurt, , Germany
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet, Greifswald, , Germany
Marien Hospital, Hagen, , Germany
Allgemeines Krankenhaus Hagen, Hagen, , Germany
Martin Luther Universitaet, Halle Saale, , Germany
Internistisch - Onkologische Gemeinschaftspraxis, Halle, , Germany
Hermann-Holthusen Institute for Radiotherapy, Hamburg, , Germany
Haematologisch-Onkologische Praxis Altona, Hamburg, , Germany
Evangelische Krankenhaus Hamm, Hamm, , Germany
Henriettenstiftung - Chirurgische Klinik, Hannover, , Germany
Krankenhaus Siloah - Medizinische Klinik II, Hannover, , Germany
Medizinische Hochschule Hannover, Hannover, , 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, Tuebingen, , Germany
Klinikum der Universitaet Ulm, Ulm, , Germany
Harz-Klinikum Wernigerode GMBH - Medizinische Klinik, Wernigerode, , Germany
Klinikum der Stadt Wolfsburg, Wolfsburg, , Germany
Gemeinschaftspraxis, Worms, , Germany
Medizinische Poliklinik, Universitaet Wuerzburg, Wuerzburg, , Germany
Witten University - Klinikum Wuppertal, Wuppertal, , Germany
Ospedale San Lazzaro, Alba, , Italy
Saint Laurentius Ziekenhuis, Roermond, , Netherlands
Russian Academy of Medical Sciences Cancer Research Center, Moscow, , Russian Federation
Medical Oncology Centre of Rosebank, Johannesburg, , South Africa
Contact Details
Name: Claus-Henning Koehne, MD
Affiliation: Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Role: STUDY_CHAIR
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