BAY 59-8862 in Treating Patients With Advanced Kidney Cancer
- Conditions
- Kidney Cancer
- Registration Number
- NCT00039169
- Lead Sponsor
- Theradex
- Brief Summary
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 BAY 59-8862 in treating patients who have advanced kidney cancer.
- Detailed Description
OBJECTIVES:
* Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with advanced renal cell cancer treated with BAY 59-8862.
* Determine the overall survival in patients treated with this drug.
* Determine the time to progression in patients treated with this drug.
* Determine the duration of response (CR and PR) in patients treated with this drug.
* Determine the qualitative and quantitative toxicity profile of this drug in this patient population.
* Determine the pharmacokinetic profile of this drug in selected patients.
OUTLINE: This is a multicenter study.
Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months thereafter or for up to 2 years.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- 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 (13)
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Medical Consultants
🇺🇸Muncie, Indiana, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
206 Research Associates
🇺🇸Greenbelt, Maryland, United States
Billings Oncology Associates
🇺🇸Billings, Montana, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada