Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer

Case Comprehensive Cancer Center32 enrolled

Overview

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.

OBJECTIVES: * 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Cancer

Interventions

cisplatinDRUG

Cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

gemcitabine hydrochlorideDRUG

Gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.

Time frame: Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Data from ClinicalTrials.gov

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