BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00039156|
Recruitment Status : Unknown
Verified January 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : July 24, 2008
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer 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 refractory non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: ortataxel||Phase 2|
- Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with aggressive refractory non-Hodgkin's lymphoma 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, open-label 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 for up to 2 years.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma|
|Study Start Date :||January 2002|
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): NCT00039156
|United States, Florida|
|Mount Sinai Comprehensive Cancer Center|
|Miami Beach, Florida, United States, 33140|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Louisiana|
|Veterans Affairs Medical Center - Shreveport|
|Shreveport, Louisiana, United States, 71101|
|Louisiana State University Health Sciences Center - Shreveport|
|Shreveport, Louisiana, United States, 71130-3932|
|United States, New Jersey|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|Albert Einstein Clinical Cancer Center|
|Bronx, New York, United States, 10461|
|Brooklyn, New York, United States, 11235|
|North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|State University of New York - Upstate Medical University|
|Syracuse, New York, United States, 13210|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|United States, Tennessee|
|Memphis, Tennessee, United States, 38120|
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226-3596|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|St. Paul's Hospital - Vancouver|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Study Chair:||Rasim Ahmet Gucalp, MD||Montefiore Medical Center|