NCT00007943CompletedPhase 2
A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer
Wake Forest University Health Sciences1 site in 1 country15 target enrollmentStarted: September 1, 2000Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •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
- •Cardiovascular:
- •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:
- •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
- •More than 4 weeks since prior surgery
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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