Gemcitabine in Treating Patients With Advanced Colorectal Cancer

You may be eligible if

• DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer that has failed at least 1
• prior course of fluoropyrimidine-based chemotherapy
• Measurable and/or evaluable disease
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• 0-2
• Life expectancy:
• At least 3 months
• Hematopoietic:
• WBC at least 3,000/mm3
• Platelet count at least 100,000/mm3
• Hepatic:
• Bilirubin no greater than 2.5 times upper limit of normal (ULN)
• ALT and/or AST no greater than 3 times ULN (no greater than 10 times ULN if
• secondary to hepatic involvement by tumor
• Renal:
• Creatinine no greater than 2.0 mg/dL
• Cardiovascular:
• No history of cardiac arrhythmias requiring chronic treatment beyond an
• acute event (e.g., arrhythmias during severe electrolyte abnormalities
• allowed)
• No active cardiac disease requiring treatment other than hypertension,
• stable angina, or chronic valvular disease
• Other:
• No other malignancy within the past 5 years except curatively treated
• (including surgically cured) cancer
• No serious medical or psychiatric illness that would preclude study
• No active uncontrolled bacterial, fungal, or viral infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Not specified
• Chemotherapy:
• See Disease Characteristics
• No more than 3 prior chemotherapy regimens
• Must have 1 prior fluorouracil-based regimen and 1 other cytotoxic agent
• (e.g., irinotecan)
• More than 4 weeks since prior chemotherapy
• Prior gemcitabine allowed
• No other concurrent antineoplastic therapy
• Endocrine therapy:
• Not specified
• Radiotherapy:
• More than 4 weeks since prior radiotherapy
• Surgery:
• More than 4 weeks since prior surgery