A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rakesh Singal, University of Miami
ClinicalTrials.gov Identifier:
NCT00503984
First received: July 17, 2007
Last updated: December 9, 2015
Last verified: December 2015
Results First Received: December 9, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Prostate Cancer
Pain
Interventions: Drug: Azacitidine
Drug: Docetaxel
Drug: Prednisone
Genetic: GADD45α methylation and expression analysis
Drug: Pegfilgrastim
Drug: Filgrastim

  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
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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
Phase 1 - Aza + Doc Dose Escalation

Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; Growth Arrest and DNA Damage inducible alpha (GADD45α) methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).

Azacitidine: Intravenous infusion over 30 minutes Days 1 - 5 of each 3 weekly cycle.

Docetaxel: Intravenous infusion over 1 hour on day 6 of each 3 weekly cycle.

Prednisone: Patient will receive prednisone 5mg twice a day from Day 1 to 21 of each cycle.

GADD45α methylation and expression analysis: Peripheral blood samples from patients will be collected as described in section 8.1 (total of 4 blood samples). DNA will be isolated from serum, bisulfite treated and evaluated for methylation by bisulfite genomic sequencing.

Patients with accessible prostate tissue or metastases will undergo biopsy prior to treatment if they consent to do so.

Phase 2 - Aza + Doc RPTD

Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).

Azacitidine: Intravenous infusion over 30 minutes Days 1 - 5 of each 3 weekly cycle.

Docetaxel: Intravenous infusion over 1 hour on day 6 of each 3 weekly cycle.

Prednisone: Patient will receive prednisone 5mg twice a day from Day 1 to 21 of each cycle.


Participant Flow:   Overall Study
    Phase 1 - Aza + Doc Dose Escalation     Phase 2 - Aza + Doc RPTD  
STARTED     15     7  
COMPLETED     15     7  
NOT COMPLETED     0     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.
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Reporting Groups
  Description
Phase 1 - Aza + Doc Dose Escalation

Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).

Azacitidine: Intravenous infusion over 30 minutes Days 1 - 5 of each 3 weekly cycle.

Docetaxel: Intravenous infusion over 1 hour on day 6 of each 3 weekly cycle.

Prednisone: Patient will receive prednisone 5mg twice a day from Day 1 to 21 of each cycle.

GADD45α methylation and expression analysis: Peripheral blood samples from patients will be collected as described in section 8.1 (total of 4 blood samples). DNA will be isolated from serum, bisulfite treated and evaluated for methylation by bisulfite genomic sequencing.

Patients with accessible prostate tissue or metastases will undergo biopsy prior to treatment if they consent to do so.

Phase 2 - Aza + Doc RPTD

Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).

Azacitidine: Intravenous infusion over 30 minutes Days 1 - 5 of each 3 weekly cycle.

Docetaxel: Intravenous infusion over 1 hour on day 6 of each 3 weekly cycle.

Prednisone: Patient will receive prednisone 5mg twice a day from Day 1 to 21 of each cycle.

Total Total of all reporting groups

Baseline Measures
    Phase 1 - Aza + Doc Dose Escalation     Phase 2 - Aza + Doc RPTD     Total  
Number of Participants  
[units: participants]
  15     7     22  
Age, Customized  
[units: participants]
     
< 60 years     3     1     4  
60 - 69 years     8     3     11  
>= 70 years     4     3     7  
Gender  
[units: participants]
     
Female     0     0     0  
Male     15     7     22  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     5     1     6  
Not Hispanic or Latino     10     6     16  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     4     1     5  
White     11     6     17  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     15     7     22  



  Outcome Measures
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1.  Primary:   Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine, Docetaxel and Prednisone Combination.   [ Time Frame: Up to 1.5 years ]

2.  Primary:   Number of Participants Achieving Prostate-specific Antigen (PSA) Response.   [ Time Frame: Up to 4.5 years. ]

3.  Primary:   Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.   [ Time Frame: Up to 4.5 years ]

4.  Secondary:   Duration of Response   [ Time Frame: Up to 4.5 years. ]

5.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Up to 4.5 years ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 4.5 years. ]

7.  Secondary:   Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy.   [ Time Frame: Up to 4.5 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: Rakesh Singal MD
Organization: University of Miami
phone: 305-243-9544
e-mail: rsingal@med.miami.edu


Publications:

Responsible Party: Rakesh Singal, University of Miami
ClinicalTrials.gov Identifier: NCT00503984     History of Changes
Other Study ID Numbers: 20061143
SCCC-2006080 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
WIRB-20070344 ( Other Identifier: Western Institutional Review Board )
20140376 ( Other Identifier: University of Miami )
Study First Received: July 17, 2007
Results First Received: December 9, 2015
Last Updated: December 9, 2015
Health Authority: United States: Food and Drug Administration