BAY 59-8862 in Treating Patients With Advanced Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00039169|
Recruitment Status : Unknown
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 8, 2003
Last Update Posted : July 24, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: ortataxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|