A Study of Imatinib and Docetaxel in Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00251225|
Recruitment Status : Completed
First Posted : November 9, 2005
Results First Posted : August 9, 2017
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Gleevec Drug: Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Imatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer|
|Study Start Date :||August 2005|
|Primary Completion Date :||March 2009|
|Study Completion Date :||March 2014|
Experimental: Hormone Refractory Prostate Cancer
Gleevec + Docetaxel: Daily Oral Gleevec in Combination with Every-Three-Week Intravenous Docetaxel
Imatinib-400mg po qd for 10 days to commence on day 3. On day 0, Docetaxel 60mg/m^2 administered IV
Other Names:Drug: Docetaxel
60 mg/m^2 administered IV on day 0
Other Name: Taxotere
- Overall Time To Progression (TTP) [ Time Frame: Up to 24 months ]TTP is the amount of time from date of registration to date of first documentation of progression or symptomatic deterioration. For progression, one or more of the following must occur: (1) 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. (2) Increase in PSA by at least 25% from baseline in patients whose PSA did not decrease, and of 50% from nadir in patients whose PSA decreased with a confirmation 3 weeks later. (3) Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). (4) Appearance of any new lesion/site. (5) Death due to disease without prior documentation of progression and without symptomatic deterioration, which is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
- Prostate-Specific Antigen (PSA) Response Rate [ Time Frame: Up to 12 months ]PSA response rate is the number of participants who experienced a best response of: complete response, CR (PSA less than or equal to 0.2 ng/mL, documented two or more times, a minimum of four weeks apart), partial response, PR (a decline in PSA by at least 50%, confirmed by a second PSA value four or more weeks later) or stable disease (does not qualify for CR, PR, Progression or Symptomatic Deterioration, at least 6 weeks after registration) / total number of analyzable patients.
- Overall Survival (OS) [ Time Frame: Up to 60 months ]OS is the amount of time in months from the date of registration to the date of death from any cause.
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): NCT00251225
|United States, Pennsylvania|
|Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Leonard J Appleman, MD||University of Pittsburgh|