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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 
Overall Participants Analyzed 
[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



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00110214     History of Changes
Other Study ID Numbers: NCI-2012-02814
NCI-2012-02814 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000427290
CALGB-90401 ( Other Identifier: Cancer and Leukemia Group B )
CALGB-90401 ( Other Identifier: CTEP )
P30CA014236 ( US NIH Grant/Contract Award Number )
U10CA031946 ( US NIH Grant/Contract Award Number )
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