Colorectal Cancer
Conditions
Keywords
stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Brief 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 gemcitabine in treating patients who have advanced colorectal cancer.
Detailed description
OBJECTIVES: * Determine the response rate in patients with advanced colorectal cancer treated with gemcitabine. * 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 unacceptable toxicity. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 12-41 patients will be accrued for this study within 2 years.
Interventions
DRUGgemcitabine hydrochloride
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed