Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer (NCT00003928) | Clinical Trial Compass
CompletedPhase 2
Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer
United States32 participantsStarted 1999-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.
Timeframe: Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.