OBJECTIVES:
* Determine the feasibility of enrolling patients aged 70 and over with unresectable metastatic or recurrent colorectal cancer to a structured phase II study.
* Determine the anticancer efficacy of capecitabine, in terms of objective response rate (confirmed and unconfirmed, complete and partial responses) and 2-year survival, in these patients.
* Determine the toxicity and tolerability of this drug in these patients.
* Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status of patients treated with this drug.
* Determine the clinical pharmacology of this drug in these patients.
* Determine whether patients under 60 years of age treated with this drug have clinical pharmacologic parameters similar to those reported in the literature.
OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs 18 to 59).
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 80 patients (60 patients aged 70 and over, 20 patients aged 18 to 59) will be accrued for this study.
