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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:
ClinicalTrials.gov Identifier:
NCT00604461
First Posted: January 30, 2008
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
Results First Submitted: November 17, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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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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
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 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      6  46.2% 
>=65 years      7  53.8% 
Age, Customized 
[Units: Years]
Median (Full Range)
 66 
 (41 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1   7.7% 
Male      12  92.3% 
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 ]

2.  Secondary:   Number of Months of Progression Free Survival (PFS)   [ Time Frame: 2 Years, 9 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
This trial was closed early due to slow patient accrual. The planned accrual had been 44.


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



Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00604461     History of Changes
Other Study ID Numbers: MCC-14896
AVF3483s ( Other Identifier: Genentech )
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: November 17, 2011
Results First Posted: December 26, 2011
Last Update Posted: March 23, 2017