Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer

This study has been terminated.
(Lack of improved efficacy compared to historical controls, competing studies)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00786682
First received: November 5, 2008
Last updated: September 23, 2013
Last verified: September 2013
Results First Received: September 23, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: docetaxel
Drug: hydroxychloroquine

  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
Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and a community hospital in New Jersey, part of the CINJ Oncology Group, from February 2009 through August 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Docetaxel and Hydroxychloroquine

Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle

Drug: hydroxychloroquine 200 mg twice daily

A cycle is defined as an interval of 21 days.


Participant Flow:   Overall Study
    Docetaxel and Hydroxychloroquine  
STARTED     11  
COMPLETED     11  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Docetaxel and Hydroxychloroquine

Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle

Drug: hydroxychloroquine 200 mg twice daily

A cycle is defined as an interval of 21 days.


Baseline Measures
    Docetaxel and Hydroxychloroquine  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation
  65.7  ± 6.0  
Gender  
[units: participants]
 
Female     0  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     11  



  Outcome Measures
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1.  Primary:   Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.   [ Time Frame: 4 years ]

2.  Secondary:   Time to Disease Progression   [ Time Frame: 10 years ]

3.  Secondary:   Overall Survival   [ Time Frame: 10 years ]


  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. Mark Stein
Organization: Cancer Institute of New Jersey
phone: 732-235-8675
e-mail: steinmn@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu


No publications provided


Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00786682     History of Changes
Other Study ID Numbers: CDR0000617998, P30CA072720, CINJ-080805
Study First Received: November 5, 2008
Results First Received: September 23, 2013
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration