Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum Metastatic disease Measurable disease Patients who received prior radiotherapy must have measurable or evaluable disease outside the radiotherapy field No CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2 times upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases) Renal Creatinine clearance at least 51 mL/min No severe renal impairment Cardiovascular No severe cardiac disease No uncontrolled angina pectoris No myocardial infarction within the past 6 months Other Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study participation No active Crohn's disease No other malignancy except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer No other uncontrolled severe medical condition No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent active or passive immunotherapy for colon cancer Chemotherapy No prior chemotherapy for metastatic disease Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery Not specified Other At least 6 months since prior adjuvant therapy More than 4 weeks since prior investigational drugs No concurrent sorivudine or chemically related analogues (e.g., brivudine) No other concurrent investigational drugs No other concurrent cytotoxic agents No concurrent prophylactic fluconazole No concurrent or planned cyclo-oxygenase-2 (COX-2) inhibitors or nonsteroidal anti-inflammatory drugs No concurrent chronic use of full-dose aspirin (325 mg/day or greater) Concurrent low-dose (cardioprotective) aspirin prophylaxis (no more than 325 mg every other day OR no more than 162.5 mg per day) allowed
Sites / Locations
- Ziekenhuis Network Antwerpen Middelheim
- Institut Jules Bordet
- Academisch Ziekenhuis der Vrije Universiteit Brussel
- Universitair Ziekenhuis Antwerpen
- Cazk Groeninghe - Campus St-Niklaas
- St. Elizabeth Ziekenhuis
- National Cancer Institute - Cairo
- Charite - Campus Charite Mitte
- General Hospital
- Universitatsklinikum Carl Gustav Carl Carus
- Kliniken Essen - Mitte
- Klinikum der J.W. Goethe Universitaet
- Klinikum der Albert - Ludwigs - Universitaet Freiburg
- Allgemeines Krankenhaus Hagen
- Allgemeines Krankenhaus Altona
- Universitaets-Krankenhaus Eppendorf
- St. Marien Hospital
- Westpfalz-Klinikum GmbH
- Vinzentiuskrankenhaus
- Onkologische Schwerpunktpraxis Leer
- Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
- Kreiskrankenhaus Meissen
- Klinikum Rechts Der Isar - Technische Universitaet Muenchen
- Eberhard Karls Universitaet
- Universitaets-Hautklinik Wuerzburg
- National Institute of Oncology
- Rambam Medical Center
- Wolfson Medical Center