capecitabine and irinotecan in treating patients with locally advanced, recurrent, or metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: purpose: phase ii trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.

objectives: primary: * determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan. secondary: * determine the time to treatment failure, time to overall response, duration of overall response, duration of overall complete response, and time to progression in patients treated with this regimen. * determine the 1-year survival and overall survival of patients treated with this regimen. * determine the toxicity and safety profile of this regimen in these patients. * determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen. outline: this is a multicenter study. patients receive oral capecitabine twice daily on days 2-15 and irinotecan iv over 90 minutes on days 1 and 8. treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator. patients are followed every 3 months. projected accrual: a total of 65 patients will be accrued for this study within 9 months.

Eligibility criteria:
disease characteristics: * histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma * at least 1 measurable lesion * at least 10 mm by spiral ct scan * at least 20 mm by conventional techniques * bone metastases, ascites, or pleural effusions are not considered measurable disease * no evidence of cns metastases patient characteristics: age: * 18 and over performance status: * karnofsky 80-100% life expectancy: * not specified hematopoietic: * neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.25 times upper limit of normal (uln) * alt and ast no greater than 2.5 times uln (5 times uln if liver metastases present) * alkaline phosphatase no greater than 2.5 times uln (5 times uln if liver metastases present or 10 times uln if bone metastases present) * no known gilbert's disease renal: * creatinine no greater than 1.5 times uln * creatinine clearance at least 50 ml/min cardiovascular: * no clinically significant cardiac disease * no congestive heart failure * no symptomatic coronary artery disease * no cardiac arrhythmias uncontrolled with medication * no myocardial infarction within the past 12 months gastrointestinal: * able to swallow tablets * no lack of physical integrity of the upper gastrointestinal tract * no malabsorption syndrome other: * no prior unanticipated severe reaction to fluoropyrimidine therapy * no hypersensitivity to fluorouracil * no history of uncontrolled seizures or cns disorders * no psychological illness or condition that would preclude study entry * no other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * no serious infection * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * at least 12 months since prior neoadjuvant or adjuvant, active or passive immunotherapy * no concurrent active or passive immunotherapy (e.g., 17-1a antibody) for colon cancer * no concurrent prophylactic hematopoietic growth factors chemotherapy: * at least 12 months since prior neoadjuvant or adjuvant cytotoxic chemotherapy * no prior chemotherapy for metastatic colorectal cancer * no prior therapy with irinotecan or capecitabine * no other concurrent cytotoxic agents endocrine therapy: * not specified radiotherapy: * at least 4 weeks since prior radiotherapy * no prior radiotherapy to measurable lesion (newly arising lesions in a previously irradiated area allowed) * no concurrent radiotherapy surgery: * at least 4 weeks since prior major surgery and recovered * no prior organ allograft other: * at least 4 weeks since prior participation in an investigational drug study * no other concurrent investigational drugs

Keywords: stage iii colon cancer stage iv colon cancer stage iii rectal cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum