Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer

OBJECTIVES:

• Determine the response rate in patients with epithelial (clear or nonclear cell) renal cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan hydrochloride.
• Compare the response in patients with clear cell RCC vs nonclear cell RCC treated with this regimen.
• Determine the toxicities of this regimen.

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.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed epithelial renal cell carcinoma (RCC), including either clear cell or nonclear cell RCC
• Strong clinical evidence or biopsy proof of metastases to a site or sites distant from the primary tumor
• Measurable disease
• No untreated or progressive CNS metastases

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:

• Serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
• Congestive heart failure
• Angina pectoris
• Other severe cardiovascular disease producing limitations of physical activity (i.e., New York Heart Association class III-IV heart disease)
• No other prior malignancy except for the following:

• Basal cell or squamous cell carcinoma of the skin
• Carcinoma in situ of the uterine cervix
• Any malignancy treated with curative intent and in complete remission for > 3 years
• 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:

• Recovered from prior hormonal therapy, radiotherapy, biologic therapy, or chemotherapy
• No more than 3 prior therapeutic regimens for metastatic disease
• No prior organ allograft
• More than 28 days since prior major surgery requiring general anesthesia
• More than 28 days since prior radiotherapy to control pain from skeletal lesions
• More than 28 days since prior hormonal treatment