Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Cisplatin, Pemetrexed and Bevacizumab in Untreated Malignant Mesothelioma|
- Progression Free Survival Rate at 6 Months [ Time Frame: patients progression free at 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]overall survival was measured from time of initiation of treatment to death from any cause
|Study Start Date:||February 2006|
|Study Completion Date:||August 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
cisplatin, pemetrexed, and bevacizumab
15 mg/kg IV every 3 weeksDrug: cisplatin
75 mg/m2 IV every 3 weeksDrug: pemetrexed
500 mg/m2 every 3 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|