Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

Inclusion 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