s0030: capecitabine in treating older patients w/metastatic or recurrent colorectal cancer that cannot be surgically removed

Conditions: Colorectal Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of capecitabine in treating older patients who have metastatic or recurrent colorectal cancer that cannot be surgically removed.

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.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed metastatic or recurrent colorectal cancer not amenable to surgical resection * measurable disease * no known brain metastases by mri or ct scan patient characteristics: age * 70 and over or * 18 to 59 performance status * zubrod 0-2 life expectancy * not specified hematopoietic * absolute granulocyte count at least 1,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * bilirubin no greater than 2 times upper limit of normal (uln) * sgot (serum glutamate oxaloacetate transaminase) or sgpt (serum glutamate pyruvate transaminase) no greater than 2 times uln renal * creatinine no greater than 2 times uln * creatinine clearance greater than 50 ml/min other * not pregnant or nursing * fertile patients must use effective contraception * hiv negative * no known seizure disorder * no other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage i or ii cancer currently in complete remission, or any other cancer for which the patient has been disease free for 5 years prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior chemotherapy for advanced cancer * prior adjuvant chemotherapy allowed provided recurrence occurred more than 1 year after the last treatment endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * at least 4 weeks since prior sorivudine or brivudine * no concurrent sorivudine or brivudine

Keywords: recurrent colon cancer stage iv colon cancer recurrent rectal cancer stage iv rectal cancer