Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
Eligibility 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
Sites / Locations
- Hollings Cancer Center at Medical University of South Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Arms of the Study
Arm 1
Experimental
Gemcitabine + Irinotecan