Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00499694
First received: July 10, 2007
Last updated: August 9, 2014
Last verified: August 2014
Results First Received: August 9, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Biological: bevacizumab
Drug: satraplatin

  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
No text entered.

Reporting Groups
  Description
Bevacizumab and Satraplatin

Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days

bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days


Participant Flow:   Overall Study
    Bevacizumab and Satraplatin  
STARTED     31  
COMPLETED     30  
NOT COMPLETED     1  
Patient never received treatment.                 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.
No text entered.

Reporting Groups
  Description
Bevacizumab and Satraplatin

Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days

bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days


Baseline Measures
    Bevacizumab and Satraplatin  
Number of Participants  
[units: participants]
  31  
Age  
[units: years]
Mean ± Standard Deviation
  67.5  ± 8.5  
Gender  
[units: participants]
 
Female     0  
Male     31  
Region of Enrollment  
[units: participants]
 
United States     31  



  Outcome Measures

1.  Primary:   Time to Progression   [ Time Frame: Every 70 days ]

2.  Secondary:   Toxicity   [ Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Prostate-specific Antigen (PSA) Response Rate   [ Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Overall Survival   [ Time Frame: Followed every 3 months after treatment is discontinued ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in Levels of N-terminal Collagen Peptide (NTX) and Bone-specific Alkaline Phosphatase (BSAP)   [ Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Correlation of Urine NTX and Serum BSAP Levels With Time to Progression   [ Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
Small sample size, correlative ERCC testing conducted in only a subset of patients (14 of 30 pts) and the findings of this study are hypothesis generating however validation in larger sample size would be needed.


  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: Ulka Vaishampayan, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
phone: (313) 576-8718
e-mail: vaishamu@karmanos.org


No publications provided


Responsible Party: Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00499694     History of Changes
Other Study ID Numbers: CDR0000518085, P30CA022453, WSU-2006-118
Study First Received: July 10, 2007
Results First Received: August 9, 2014
Last Updated: August 9, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration