Overview
Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer
Status:
Completed
Completed
Trial end date:
2006-04-01
2006-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Case Comprehensive Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Cisplatin
Gemcitabine
Criteria
DISEASE CHARACTERISTICS:- Histologically proven metastatic renal cell carcinoma
- No brain metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 3,500/mm^3
- Hematocrit at least 30%
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- AST and ALT no greater than 1.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No uncontrolled hypertension
- No myocardial infarction within the past 8 weeks
Other:
- 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
bladder cancer
- No significant psychiatric disease
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No more than 2 prior biologic response modifier regimens
- No concurrent biologic therapy
Chemotherapy:
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior radiotherapy allowed if measurable disease is outside radiation port
- At least 28 days since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- Prior surgery allowed