Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer.

OBJECTIVES: Primary * Determine the efficacy of capecitabine and oxaliplatin as first-line treatment, as defined by stabilization or improvement by 1 point on Katz's Activities of Daily Living scale, in older patients with metastatic colorectal adenocarcinoma. Secondary * Determine the toxicity of this regimen in these patients. * Determine the percentage of patients who receive the first 3 courses of this regimen (at lower doses) and the percentage of patients who receive all 6 courses of this regimen (at both lower and higher doses). * Determine efficacy of this regimen, as defined by RECIST criteria, in these patients. * Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a multicenter, open-label, nonrandomized study. 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. NOTE: \*The doses of both capecitabine and oxaliplatin are increased in courses 4-6 in the absence of unacceptable toxicity PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.