Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	NCI	CWRU-3897 NCI-G99-1530, NCT00003928

Objectives

1. Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.
2. Assess toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven metastatic renal cell carcinoma



• No brain metastases

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,500/mm³
• Hematocrit at least 30%
• Platelet count at least 100,000/mm³

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

Expected Enrollment

Approximately 29-38 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Scot Remick, MD, Protocol chair		Ph: 216-844-5412

Registry Information
Official Title		A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients with Renal Cell Carcinoma
Trial Start Date		1999-01-19
Registered in ClinicalTrials.gov		NCT00003928
Date Submitted to PDQ		1999-06-09
Information Last Verified		2005-02-02
NCI Grant/Contract Number		P30-CA43703

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