Kidney Cancer Clinical Trial
Official title:
A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma
Verified date | June 2010 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | April 2006 |
Est. primary completion date | February 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin. | Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | No |
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