Expired Study
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Winston-Salem, North Carolina 27157


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Paul D. Savage, MD
Wake Forest University Health Sciences

Backup Contact:


Location Contact:

Winston-Salem, North Carolina 27157
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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