BAY 59-8862 in Treating Patients With Advanced Kidney Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||An Uncontrolled Phase II Multi-Center Trial Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Advanced Renal Cell Cancer|
|Study Start Date:||December 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039169
|United States, California|
|La Jolla, California, United States, 92037|
|United States, Indiana|
|Muncie, Indiana, United States, 47303|
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70121|
|United States, Maryland|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland|
|Baltimore, Maryland, United States, 21201|
|206 Research Associates|
|Greenbelt, Maryland, United States, 20770|
|United States, Missouri|
|St. Louis University Health Sciences Center|
|Saint Louis, Missouri, United States, 63110-0250|
|United States, Montana|
|Billings Oncology Associates|
|Billings, Montana, United States, 59101|
|United States, New Jersey|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|State University of New York - Upstate Medical University|
|Syracuse, New York, United States, 13210|
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Tom Baker Cancer Center - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Study Chair:||Marius Moscovici, MD||Pharma-Clinical|