Multimodality Phase II Study in Prostate Cancer

This study has been terminated.
(Dose Limiting Toxicities)
Sponsor:
Collaborators:
Pfizer
Sanofi
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734851
First received: August 13, 2008
Last updated: November 18, 2015
Last verified: September 2015
Results First Received: September 21, 2015  
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: Sunitinib
Radiation: EBXRT

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
36 participants consented. 2 participants withdrew consent prior to going on treatment. 34 participants started treatment. 2 participants withdrew while on treatment. 18 withdrawn by PI.

Reporting Groups
  Description
Multimodality 4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks

Participant Flow:   Overall Study
    Multimodality  
STARTED     34  
COMPLETED     13  
NOT COMPLETED     21  
Withdrawal by Subject                 2  
Lost to Follow-up                 1  
Physician Decision                 18  



  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
Multimodality 4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks

Baseline Measures
    Multimodality  
Number of Participants  
[units: participants]
  34  
Age  
[units: years]
Mean (Standard Deviation)
  60.76  (7.22)  
Gender  
[units: participants]
 
Female     0  
Male     34  



  Outcome Measures
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1.  Primary:   The Rate of Progression Free Survival (PFS) at 24 Months   [ Time Frame: 2 years ]

2.  Secondary:   Proportion of Biochemical Progression (bPFS Proportion) at 2 and 3 Years.   [ Time Frame: 24 months and 36 months ]

3.  Secondary:   Rate of Local Recurrence at 2 and 3 Years   [ Time Frame: 24 months and 36 months ]

4.  Secondary:   Metastasis-free Survival (MFS) Rates at 2 and 3 Years.   [ Time Frame: 2 and 3 years ]

5.  Secondary:   Change in Quality of Life (QoL) After 1 Year   [ Time Frame: baseline and 1 year ]

6.  Secondary:   Change in Quality of Life (QoL) After 3 Month   [ Time Frame: baseline and 3 months ]

7.  Secondary:   Comparison of RNA Expression Profile From Original Prostate Radical Prostatectomy Specimen Among Those With PSA Relapse at 2 and 3 Years as Compared to Those Without PSA Relapse at the Primary Endpoint.   [ Time Frame: 2 and 3 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: Andrew J. Armstrong, MD ScM FACP
Organization: DukeUMC
phone: (919) 668-8797
e-mail: andrew.armstrong@duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734851     History of Changes
Other Study ID Numbers: Pro00010747
Study First Received: August 13, 2008
Results First Received: September 21, 2015
Last Updated: November 18, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board