Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT00295503|
Recruitment Status : Completed
First Posted : February 23, 2006
Results First Posted : January 5, 2017
Last Update Posted : January 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: bevacizumab Drug: cisplatin Drug: pemetrexed||Phase 2|
Secondary endpoints will include:
objective response rate
In addition, the objective of the analysis of the correlative science data is to determine any association between tumor expression of VEGF/KDR complex and/or the presence of sv40 (as detected by PCR amplification) and objective response.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Cisplatin, Pemetrexed and Bevacizumab in Untreated Malignant Mesothelioma|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||August 2010|
cisplatin, pemetrexed, and bevacizumab
15 mg/kg IV every 3 weeks
75 mg/m2 IV every 3 weeks
500 mg/m2 every 3 weeks
- Progression Free Survival Rate at 6 Months [ Time Frame: patients progression free at 6 months ]This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.
- 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 ]response was assessed by the RECIST criteria (version 1.0). Per those criteria, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- 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. ]overall survival was measured from time of initiation of treatment to death from any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295503
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390-8852|
|Principal Investigator:||Jonathan E Dowell, MD||University of Texas|