Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Completed; Phase 2

Conditions: Kidney Cancer

Treatments: Drug: gemcitabine hydrochloride; Drug: cisplatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003928

CWRU-3897

P30CA043703 (U.S. NIH Grant/Contract)

CWRU3897

NCI-G99-1530

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)