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 gemcitabine in treating patients who
have advanced colorectal cancer.
- Determine the response rate in patients with advanced colorectal cancer treated with
- Determine the toxic effects of this drug in these patients.
- Determine the progression-free survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV continuously over 24 hours on days 1, 8, and 15. Treatment
repeats every 28 days for a total of 6 courses in the absence of disease progression or
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 12-41 patients will be accrued for this study within 2 years.
DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer that has
failed at least 1
prior course of fluoropyrimidine-based chemotherapy
Measurable and/or evaluable disease
- 18 and over
- At least 3 months
- WBC at least 3,000/mm3
- Platelet count at least 100,000/mm3
- 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
- Creatinine no greater than 2.0 mg/dL
- No history of cardiac arrhythmias requiring chronic treatment beyond an
- acute event (e.g., arrhythmias during severe electrolyte abnormalities
- No active cardiac disease requiring treatment other than hypertension,
- stable angina, or chronic valvular disease
- 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:
- Not specified
- 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
- Not specified
- More than 4 weeks since prior radiotherapy
- More than 4 weeks since prior surgery