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Docetaxel, Thalidomide, Prednisone, and Bevacizumab to Treat Metastatic Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
William Dahut Jr., M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00089609
First received: August 6, 2004
Last updated: September 16, 2016
Last verified: September 2016
Results First Received: October 12, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostatic Neoplasms
Interventions: Drug: Docetaxel
Drug: Thalidomide
Drug: Prednisone
Biological: bevacizumab
Genetic: polymorphism analysis
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Other: pharmacological study

  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
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Reporting Groups
  Description
Main Cohort - Prostate Cancer Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
Expansion Cohort - Prostate Cancer Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.

Participant Flow:   Overall Study
    Main Cohort - Prostate Cancer   Expansion Cohort - Prostate Cancer
STARTED   60   13 
COMPLETED   57   12 
NOT COMPLETED   3   1 
Withdrawal by Subject                3                1 



  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
Main Cohort - Prostate Cancer Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
Expansion Cohort - Prostate Cancer Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
Total Total of all reporting groups

Baseline Measures
   Main Cohort - Prostate Cancer   Expansion Cohort - Prostate Cancer   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   13   73 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   29   8   37 
>=65 years   31   5   36 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.35  (7.81)   63.31  (8.74)   64.98  (7.96) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   60   13   73 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   3   1   4 
Not Hispanic or Latino   56   12   68 
Unknown or Not Reported   1   0   1 
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   9   2   11 
White   51   11   62 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   60   13   73 


  Outcome Measures
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1.  Primary:   Number of Participants Who Had a Prostate-specific Antigen (PSA) Response   [ Time Frame: 21.6 months ]

2.  Primary:   Immune Response   [ Time Frame: 6 weeks ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 37 months ]

4.  Secondary:   Time to Progression Using Bubley Criteria   [ Time Frame: up to 40 months ]

5.  Secondary:   Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)   [ Time Frame: up to 34 months ]

6.  Secondary:   Number of Participants Who Died After a Follow Up of 34 Months Following Treatment   [ Time Frame: 34 months ]

7.  Secondary:   Plasma Concentrations of Docetaxel and Thalidomide and Clinical Activity or Toxicity   [ Time Frame: Pre-dose on C1D1, 5 minutes before the end of infusion, and 15, and 30 minutes, and 1, 2,4,8, and 24 hours after the end of infusion ]

8.  Secondary:   Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level   [ Time Frame: Baseline and at 6 weeks (after two cycles of treatment) ]

9.  Secondary:   Analyze the Patients Genotype With Regard to Cytochrome P450 2C19 Polymorphism and Correlate That With Pharmacokinetics and Efficacy   [ Time Frame: Patient entry onto the study ]

10.  Secondary:   Usefulness of Dynamic Magnetic Resonance Imaging (MRI) to Monitor the Progression of Bony and Soft Tissue Disease in Metastatic Prostate Cancer   [ Time Frame: Baseline and at 3 month intervals until progression ]

11.  Secondary:   Changes in the Molecular Markers of Angiogenesis (Including, But Not Limited to Serum and Urine Vascular Endothelial Growth Factor (VEGF)) Before and After Administration of Docetaxel, Prednisone, Thalidomide and Bevacizumab   [ Time Frame: Baseline and monthly ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: William Dahut, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-435-8183
e-mail: dahutw@mail.nih.gov


Publications:

Responsible Party: William Dahut Jr., M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00089609     History of Changes
Obsolete Identifiers: NCT00091364
Other Study ID Numbers: 040257
04-C-0257
Study First Received: August 6, 2004
Results First Received: October 12, 2012
Last Updated: September 16, 2016
Health Authority: United States: Federal Government