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About
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with irinotecan works in treating patients with metastatic kidney cancer.
Full description
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Life expectancy > 3 months
Absolute neutrophil count > 1,500/mm³
Platelet count > 100,000/mm³
Hemoglobin > 9.5 g/dL
Creatinine ≤ 1.8 mg/dL
Bilirubin < 1.5 mg/dL
Calcium < 11.5 mg/dL
ALT and AST < 3 times upper limit of normal
No history of any of the following:
No other prior malignancy except for the following:
No active peptic ulcer disease, inflammatory bowel disease, or chronic diarrhea
No local or systemic infections requiring IV antibiotics within the past 28 days
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
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Data sourced from clinicaltrials.gov
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