RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: This phase II trial is studying how well gemcitabine and cisplatin work in treating
patients with metastatic kidney cancer.
- Assess the response rate of patients with metastatic renal cell carcinoma treated with
gemcitabine and cisplatin.
- Assess toxicity of this regimen in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin
IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 4 months.
PROJECTED ACCRUAL: Approximately 29-38 patients will be accrued for this study.
- Histologically proven metastatic renal cell carcinoma
- No brain metastases
- Over 18
- ECOG 0-2
- At least 12 weeks
- WBC at least 3,500/mm^3
- Hematocrit at least 30%
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 2.0 mg/dL
- AST and ALT no greater than 1.5 times upper limit of normal
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- No uncontrolled hypertension
- No myocardial infarction within the past 8 weeks
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy within the past 5 years except nonmelanomatous skin cancer,
carcinoma in situ of cervix, prostate intraepithelial neoplasia, or superficial
- No significant psychiatric disease
- No active infection
PRIOR CONCURRENT THERAPY:
- No more than 2 prior biologic response modifier regimens
- No concurrent biologic therapy
- No prior chemotherapy
- No other concurrent chemotherapy
- Not specified
- Prior radiotherapy allowed if measurable disease is outside radiation port
- At least 28 days since prior radiotherapy
- No concurrent radiotherapy
- Prior surgery allowed
Scot C. Remick, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center