Clinical Trials for Mesothelioma Patients—A Study of Carboplatin, Bevacizumab and Pemetrexed for MPM Patients: Outcome Measures

Read about the outcome measures for a current clinical trial about the use of Carboplatin, Bevacizumab and Pemetrexed for MPM patients with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.

Official Title:

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

Primary Outcome Measures:

Determine if Overall Survival (OS) in newly diagnosed patients with MPM who are treated first-line with a regimen consisting of carboplatin, bevacizumab, and pemetrexed exceeds 12 months. [ Time Frame: 36 months ]
[ Designated as safety issue: No ]

Secondary Outcome Measures:

Estimate the progression free survival (PFS). Determine the response rates. Safety of the regimen will also be assessed. [ Time Frame: Patient will be taken off the study at the time of progression. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: October 2007
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)

Arms and Assigned Interventions:
A, B: Experimental; A: Tiered Dose Escalation/Phase II Dose; B: Maintenance Therapy Drug: Carboplatin, Bevacizumab and Pemetrexed
Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m2
Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m2
Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m2
Chemotherapy will be given for two cycles after maximal response. Patients will be taken off study at the time of progression. If the patient has stable disease or better, as a response, then patient will be maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occurs first. CT scans will be done every 12 weeks during maintenance phase.

If you have been diagnosed with an Asbestos illness like mesothelioma, lung cancer or asbestosis, complete the form on this page to get a FREE and prompt review of your case by a leading Asbestos attorney. Weitz & Luxenberg is a leading mesothelioma law firm with a substantial history of success in asbestos exposure cases.