Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed renal cell carcinoma
• •* Locally advanced unresectable or metastatic disease
• •Unidimensionally measurable disease by physical exam or imaging study
• •* The following are not considered measurable disease:
• •* Bone only disease
• •* Pleural or peritoneal effusions
• •* CNS lesions
• •* Irradiated lesions unless disease progression was documented after radiotherapy
• •PATIENT CHARACTERISTICS:
• •Age
• •Over 18
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Granulocyte count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hepatic
• •ALT and AST \< 3 times upper limit of normal
• •Bilirubin ≤ 2.0 mg/dL
• •Renal
• •Creatinine ≤ 2.0 mg/dL
• •Gastrointestinal
• •No active inflammatory bowel disease
• •No significant bowel obstruction
• •No chronic diarrhea
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 6 months after study participation
• •No mental incapacitation or psychiatric illness that would preclude giving informed consent
• •No other active malignancy except nonmelanoma skin cancer
• •No other severe disease that would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •At least 4 weeks since prior immunotherapy
• •No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
• •Chemotherapy
• •No prior chemotherapy
• •No other concurrent chemotherapy
• •Endocrine therapy
• •No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
• •Radiotherapy
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy
• •No concurrent palliative radiotherapy
• •Surgery
• •Not specified
• •Other
• •No concurrent participation in another clinical trial