Clinical Trials for Mesothelioma Patients—A Study of Avastin Plus Pemetrexed-Cisplatin: Outcome Measures

Read about the outcomes measures for a current clinical trial about the use of Avastin Plus Pemetrexed-Cisplatin Decitabine and FR901228 for patients with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only. At the current time, the study is only being conducted in Belgium and France.

Primary Outcome Measures:
% of patients with controlled disease (responder and stable patients) at 6 months

Secondary Outcome Measures:
Overall Survival [ Time Frame: month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 445
Study Start Date: February 2008
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Arms and Assigned Interventions:
1. Active Comparator Standard Chemotherapy
Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles)
Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles)
2. Experimental Standard Chemotherapy + bevacizumab (Avastin)
Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles)
Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles)

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