Capecitabine and Oxaliplatin in Treating Older 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, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of colorectal adenocarcinoma Metastatic disease Requires first-line therapy for metastatic disease PATIENT CHARACTERISTICS: Age Over 70 Performance status Katz's Activities of Daily Living scale < 6 (≤ 6 for patients ≥ 80 years of age) Life expectancy More than 3 months Hematopoietic Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic AST and ALT < 2 times normal (5 times normal if due to hepatic metastases) Bilirubin < 2 times normal (5 times normal if due to hepatic metastases) Renal Creatinine clearance > 30 mL/min Other No clinical neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 6 months since prior adjuvant chemotherapy No prior chemotherapy for metastatic disease Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Sites / Locations
- Centre Regional Francois Baclesse
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
- Hopital Europeen Georges Pompidou
- Polyclinique Francheville
- Institut Jean Godinot
- Centre Rene Huguenin
- C.H. Senlis
- Institut Claudius Regaud
- Institut Gustave Roussy
Arms of the Study
Arm 1
Experimental
Capecitabine + Oxaliplatin
Patients receive oral capecitabine once daily on days 1-14 and oxaliplatin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity