Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00587431
First received: December 21, 2007
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: January 21, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: GnRh (Leuprolide)
Drug: Testosterone Gel
Drug: Docetaxel

  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

Protocol Open to Accrual: 07/08/2003

Protocol Closed to Accrual: 02/28/2006

Primary Completion Date: 02/26/2008

Recruitment Location is the Medical Clinic


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days

GnRh (Leuprolide): Leuprolide LUPRON

Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle

Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days

Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days

GnRh (Leuprolide): Leuprolide LUPRON

Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle

Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days


Participant Flow:   Overall Study
    Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days     Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days  
STARTED     63     39  
COMPLETED     62     38  
NOT COMPLETED     1     1  
Adverse Event                 1                 0  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days

GnRh (Leuprolide): Leuprolide LUPRON

Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle

Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days

Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days

GnRh (Leuprolide): Leuprolide LUPRON

Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle

Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days

Total Total of all reporting groups

Baseline Measures
    Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days     Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days     Total  
Number of Participants  
[units: participants]
  63     39     102  
Age  
[units: years]
Median ± Standard Deviation
  65  ± 25.45584412     58.5  ± 26.1629509     61.5  ± 30.40559159  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     43     26     69  
>=65 years     20     13     33  
Gender  
[units: participants]
     
Female     0     0     0  
Male     63     39     102  
Region of Enrollment  
[units: participants]
     
United States     63     39     102  



  Outcome Measures
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1.  Primary:   PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy   [ Time Frame: Conclusion of the study (at 6 months then at 18 months post-treatment) ]

2.  Secondary:   The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.   [ Time Frame: at Cycle 1 and 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Dana Rathkopf
Organization: Memorial Sloan-Kettering Cancer Center
phone: 646-422-4379
e-mail: rathkopd@mskcc.org


No publications provided


Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00587431     History of Changes
Obsolete Identifiers: NCT00070369
Other Study ID Numbers: 03-076
Study First Received: December 21, 2007
Results First Received: January 21, 2014
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board