A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma
cisplatin
+ gemcitabine hydrochloride
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: January 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, United StatesOpen Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center in Google Maps