Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive, Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the colon or rectum Unresectable disease Documented progressive disease during first-line/palliative chemotherapy Measurable disease ≥ 1 cm that is outside prior radiation field No brain metastases PATIENT CHARACTERISTICS: WHO performance status 0-2 Life expectancy ≥ 3 months No contraindication to chemotherapy Creatinine clearance ≥ 40 mL/min Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Alkaline phosphatase ≤ 3 times normal (5 times normal if hepatic involvement) Bilirubin ≤ 1.5 times normal Transaminases ≤ 5 times normal No symptomatic coronary disease or cardiac insufficiency No enteropathy or chronic diarrhea No unresolved intestinal occlusion or subocclusion No history of severe unexpected reaction to a fluoropyrimidine No other active malignancy in the past 2 years No hypersensitivity to irinotecan hydrochloride or its excipients No hypersensitivity to capecitabine or fluorouracil PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior extensive resection No concurrent sorivudine or similar analogs (e.g., brivudine) No other concurrent anticancer therapy Concurrent radiotherapy allowed for nontarget lesions
Sites / Locations
- Centre Hospitalier d'Abbeville
- Polyclinique Bordeaux Nord Aquitaine
- Centre Hospitalier Universitaire Ambroise Pare - Boulogne
- Centre Hospitalier
- Hopital Antoine Beclere
- Hopital Du Bocage
- Clinique Pasteur
- CMC Les Ormeaux
- C. H. Du Mans
- Hopital Robert Boulin
- Polyclinique des Quatre Pavillons
- CHR D'Orleans - Hopital de la Source
- Hopital Europeen Georges Pompidou
- Hopital Bichat - Claude Bernard
- CHU Pitie-Salpetriere
- Hopital Cochin
- Centre Hospitalier de Perpignan
- Hopital Sebastopol, C.H.U. de Reims
- Centre Eugene Marquis
- Hopital Charles Nicolle
- C.H. Senlis
- CHRU de Tours - Hopital Trousseau
- Centre Hospitalier General - St. Nicolas