Colon Cancer Clinical Trial
Gemcitabine in Treating Patients With Advanced Colorectal Cancer
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Winston-Salem North Carolina, 27157, United States
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