BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
- Conditions
- Stage IV Renal Cell CancerRecurrent Renal Cell Cancer
- Registration Number
- NCT00040989
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief Summary
RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.
- Detailed Description
OBJECTIVES:
* Determine the tumor response rate of patients with recurrent, unresectable, or metastatic renal cell carcinoma treated with BAY 56-3722.
* Determine the duration of response, time to progression, and survival of patients treated with this drug.
* Determine the qualitative and quantitative toxic effects of this drug in these patients.
* Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive BAY 56-3722 IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Oregon Cancer Institute
🇺🇸Portland, Oregon, United States
Oncology-Hematology Group of South Florida
🇺🇸Miami, Florida, United States
Cancer Therapy and Research Center
🇺🇸San Antonio, Texas, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States