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

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