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

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ClinicalTrials.gov Identifier: NCT00499694
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : August 25, 2014
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Biological: bevacizumab
Drug: satraplatin

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.5  (8.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      31 100.0% 
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 ]

3.  Secondary:   Prostate-specific Antigen (PSA) Response Rate   [ Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle ]

4.  Secondary:   Overall Survival   [ Time Frame: Followed every 3 months after treatment is discontinued ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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



Responsible Party: Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00499694     History of Changes
Other Study ID Numbers: CDR0000518085
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2006-118 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
First Submitted: July 10, 2007
First Posted: July 11, 2007
Results First Submitted: August 9, 2014
Results First Posted: August 25, 2014
Last Update Posted: March 12, 2018