Gemcitabine in Treating Patients With Advanced Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer