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Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00110214
First received: May 4, 2005
Last updated: April 21, 2014
Last verified: December 2012
Results First Received: March 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Interventions: Drug: docetaxel
Other: placebo
Drug: prednisone
Biological: bevacizumab
Other: laboratory biomarker analysis

  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
Between May 2005 and December 2007, 1,050 participants were recruited and randomized

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 + Placebo Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
Docetaxel + Bevacizumab Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks

Participant Flow:   Overall Study
    Docetaxel + Placebo     Docetaxel + Bevacizumab  
STARTED     526     524  
COMPLETED     17     21  
NOT COMPLETED     509     503  
Never started treatment                 21                 20  
Disease progression or death                 260                 151  
Adverse Event                 115                 192  
Refused further treatment                 52                 65  
Other (not specified)                 61                 75  



  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 + Placebo Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
Docetaxel + Bevacizumab Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
Total Total of all reporting groups

Baseline Measures
    Docetaxel + Placebo     Docetaxel + Bevacizumab     Total  
Number of Participants  
[units: participants]
  526     524     1050  
Age  
[units: years]
Median ( Inter-Quartile Range )
  69.3  
  ( 62.4 to 75.6 )  
  68.8  
  ( 63.0 to 74.4 )  
  69.0  
  ( 62.7 to 75.2 )  
Age, Customized  
[units: participants]
     
< 65 years     174     179     353  
>=65 years     352     345     697  
Gender  
[units: participants]
     
Female     0     0     0  
Male     526     524     1050  
Region of Enrollment  
[units: participants]
     
United States     526     524     1050  
24-month predicted survival probability  
[units: participants]
     
<10%     95     94     189  
10-29.9%     184     183     367  
>=30%     247     247     494  
Prior history of arterial events  
[units: participants]
     
Yes     42     37     79  
No     484     487     971  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: Duration of study (up to 5 years) ]

2.  Secondary:   Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline   [ Time Frame: Duration of study (up to 5 years) ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Duration of study (up to 5 years) ]

4.  Secondary:   Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities   [ Time Frame: During treatment (up to 2 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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William Kevin Kelly, DO
Organization: Thomas Jefferson University
e-mail: wm.kevin.kelly@jefferson.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00110214     History of Changes
Other Study ID Numbers: NCI-2012-02814, NCI-2012-02814, CDR0000427290, CALGB-90401, CALGB-90401, P30CA014236, U10CA031946
Study First Received: May 4, 2005
Results First Received: March 7, 2013
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration