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Docetaxel (Taxotere) and Imatinib Mesylate (Gleevec) in Hormone Refractory Prostate Cancer

This study has been terminated.
(due to slow accrual)
Sponsor:
Collaborator:
Novartis
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00861471
First received: March 12, 2009
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
Results First Received: April 29, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Prostate Cancer
Prostatic Neoplasms
Interventions: Drug: Docetaxel
Drug: Imatinib Mesylate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
12 patients were enrolled between Sep. 2006 and Nov. 2008 for the Phase II part of the study in New York University Medical center and affiliated hospitals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Once the optimal combination dose of Docetaxel (Taxotere) and Gleevec (Imatinib Mesylate) was determined in the Phase I part, the study proceeded to Phase II. There were 12 patients in Phase I and Phase II, respectively. The results reported here are only for Phase II.

Reporting Groups
  Description
Docetaxel +Gleevec 21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days

Participant Flow:   Overall Study
    Docetaxel +Gleevec  
STARTED     12  
COMPLETED     3  
NOT COMPLETED     9  
Withdrawal by Subject                 1  
Adverse Event                 2  
Lack of Efficacy                 3  
treatment for lumbar laminectomy                 1  
Physician Decision                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Docetaxel +Gleevec 21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days

Baseline Measures
    Docetaxel +Gleevec  
Number of Participants  
[units: participants]
 		  12  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation 		  67.2  ± 9.9  
Gender  
[units: participants]
 		 
Female     0  
Male     12  
Region of Enrollment  
[units: participants]
 		 
United States     12  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Prostate Specific Antigen (PSA) Response   [ Time Frame: up to 9 months ]
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2.  Secondary:   Percentage of Participants With Greater or Equal to 80% PSA Reduction From Baseline Without Clinical or Radiologic Evidence of Progression   [ Time Frame: up to 9 months ]
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3.  Secondary:   Percentage of Participants With Measurable Disease Response   [ Time Frame: up to 2 years ]
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4.  Secondary:   Time to PSA Progression   [ Time Frame: up to 2 years ]
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5.  Secondary:   Median Overall Survival Time   [ Time Frame: up to 4 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was terminated before it reached the target accrual number due to slow accrual, leading to small number of subjects analyzed (12 out of the target number of 37).  


Results Point of Contact:  
Name/Title: Anna Ferrari, MD
Organization: New York University Cancer Institute
phone: 212-731-5389
e-mail: anna.ferrari@nyumc.org


No publications provided


Responsible Party: Anna Ferrari, MD, NYU Cancer Institute
ClinicalTrials.gov Identifier: NCT00861471     History of Changes
Other Study ID Numbers: NYU 04-47 (H12554), Novartis CSTI571BUS200
Study First Received: March 12, 2009
Results First Received: April 29, 2011
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board