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Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer



Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer

For Condition: recurrent renal cell cancer,stage 4 renal cell cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients who have metastatic kidney cancer.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ScotRemick,  Study Chair,  Ireland Cancer Center

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106-5065
United States
Recruiting Scot  Remick 216-844-1196


Additional Information:
Study ID Numbers:  CDR0000067117;  CWRU-3897,NCI-G99-1530
Study Start Date: 
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003928

Other Recurrent Renal Cell Cancer Studies:
1. Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer

2. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

3. Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer

4. Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer

5. Epothilone B in Treating Patients With Advanced Kidney Cancer

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