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Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma (MPM)

This study has been terminated.
(Slow Accrual)
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00604461
First received: January 17, 2008
Last updated: January 3, 2012
Last verified: November 2011
History of Changes
Results First Received: November 17, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Mesothelioma
Intervention: Drug: Carboplatin, Bevacizumab and 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
This study was Open to Accrual (recruiting) for a period of 2 years (10/04/07 through 10/05/09). Recruiting ended on 10/05/09 due to slow accrual, as requested by pharmaceutical company.

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
Dose Escalation Followed by Maintenance Therapy

A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.

B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first.

Participant Flow:   Overall Study
    Dose Escalation Followed by Maintenance Therapy  
STARTED     13  
COMPLETED     12 [1]
NOT COMPLETED     1  
[1] Death within 30 days of treatment occurred in 1 patient.



  Baseline Characteristics
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Reporting Groups
  Description
Dose Escalation Followed by Maintenance Therapy

A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.

B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first.

Baseline Measures
    Dose Escalation Followed by Maintenance Therapy  
Number of Participants  
[units: participants]
 		  13  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     7  
Age, Customized  
[units: years]
Median ( Full Range ) 		  66  
  ( 41 to 76 )  
Gender  
[units: participants]
 		 
Female     1  
Male     12  
Region of Enrollment  
[units: participants]
 		 
United States     13  



  Outcome Measures
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1.  Primary:   Number of Participants With Partial Response (PR) of Target Lesions   [ Time Frame: Up to 12 Months ]
  Show Outcome Measure 1

2.  Secondary:   Number of Months of Progression Free Survival (PFS)   [ Time Frame: 2 Years, 9 Months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
This trial was closed early due to slow patient accrual. The planned accrual had been 44.  


Results Point of Contact:  
Name/Title: Tawee Tanvetyanon, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-3050
e-mail: tawee.tanvetyanon@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00604461     History of Changes
Other Study ID Numbers: MCC-14896, AVF3483s
Study First Received: January 17, 2008
Results First Received: November 17, 2011
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board