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Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma

This study has been completed.
Sponsor:
Collaborators:
University of Chicago
Columbia University
Duke University
Information provided by (Responsible Party):
Jonathan E. Dowell, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00295503
First received: February 22, 2006
Last updated: November 4, 2016
Last verified: November 2016
Results First Received: October 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Mesothelioma
Interventions: Drug: bevacizumab
Drug: cisplatin
Drug: pemetrexed

  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
Patients recruited from investigators clinics

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
Cisplatin, Pemetrexed and Bevacizumab cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks

Participant Flow:   Overall Study
    Cisplatin, Pemetrexed and Bevacizumab
STARTED   53 
COMPLETED   53 
NOT COMPLETED   0 



  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.
one patient excluded due to ineligibility. That patient is included in the toxicity analysis

Reporting Groups
  Description
Cisplatin, Pemetrexed and Bevacizumab cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg IV every 3 weeks

Baseline Measures
   Cisplatin, Pemetrexed and Bevacizumab 
Overall Participants Analyzed 
[Units: Participants]
 52 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      24  46.2% 
>=65 years      28  53.8% 
Age 
[Units: Years]
Median (Full Range)
 66 
 (24 to 81) 
Gender 
[Units: Participants]
Count of Participants
 
Female      8  15.4% 
Male      44  84.6% 
Region of Enrollment 
[Units: Participants]
 
United States   52 


  Outcome Measures
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1.  Primary:   Progression Free Survival Rate at 6 Months   [ Time Frame: patients progression free at 6 months ]

2.  Secondary:   Response Rate   [ Time Frame: from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months ]

3.  Secondary:   Overall Survival   [ Time Frame: from time of enrollment to death from any cause. Patients still alive at study end were censored with a minimum follow up of 6 months. ]


  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: Jonathan Dowell
Organization: UT Southwestern
phone: 214-648-4180
e-mail: jonathan.dowell@utsouthwestern.edu



Responsible Party: Jonathan E. Dowell, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00295503     History of Changes
Other Study ID Numbers: AVF3442S
Study First Received: February 22, 2006
Results First Received: October 18, 2013
Last Updated: November 4, 2016
Health Authority: United States: Food and Drug Administration