Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
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
Sites / Locations
- Allgemeines Krankenhaus der Stadt Wien
- U.Z. Gasthuisberg
- National Cancer Institute of Egypt
- Institut Gustave Roussy
- PZB - Praxenzentrum
- Kreiskrankenhaus Aurich
- Haematology-Oncology
- Humaine Klinik Dresden GmbH
- Medizinische Klinik I
- Universitaetsklinik Duesseldorf
- St. Johannes Hospital - Medical Klinik II
- Hans-Susemihl-Krankenhaus
- Haemato-Onkol. Praxis
- Universitaetsklinik und Strahlenklinik - Essen
- Kliniken Essen-Mitte
- Klinikum Frankfurt (Oder)
- Klinikum der J.W. Goethe Universitaet
- Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
- Marien Hospital
- Allgemeines Krankenhaus Hagen
- Martin Luther Universitaet
- Internistisch - Onkologische Gemeinschaftspraxis
- Hermann-Holthusen Institute for Radiotherapy
- Haematologisch-Onkologische Praxis Altona
- Evangelische Krankenhaus Hamm
- Henriettenstiftung - Chirurgische Klinik
- Krankenhaus Siloah - Medizinische Klinik II
- Medizinische Hochschule Hannover
- Marienhospital/Ruhr University Bochum
- Universitatsklinik, Saarland
- Haematologisch-Oncologische Praxis
- Klinikum Lippe-Lemgo
- Stift Bethlehem
- Staedtisches Klinikum Magdeburg
- Otto-Von-Guericke-Universitaet Magdeburg
- Johannes Gutenberg University
- Muenchen Onkol. Praxis Elisenhof
- Praxis Innere Medizin
- Kreiskrankenhaus Neustadt A. Rbge. des Landkreises Hannover
- Klinikum Nurnberg
- Klinikum Ernst Von Bergmann
- Klinikum D. Ch. Erxleben
- Kreiskrankenhaus Riesa
- University of Rostock
- Fachkrankenhaus Marienstift
- Katharinenhospital
- Eberhard Karls Universitaet
- Klinikum der Universitaet Ulm
- Harz-Klinikum Wernigerode GMBH - Medizinische Klinik
- Klinikum der Stadt Wolfsburg
- Gemeinschaftspraxis
- Medizinische Poliklinik, Universitaet Wuerzburg
- Witten University - Klinikum Wuppertal
- Ospedale San Lazzaro
- Saint Laurentius Ziekenhuis
- Russian Academy of Medical Sciences Cancer Research Center
- Medical Oncology Centre of Rosebank