Official Title: “Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-Line Therapy in Patients With Malignant Pleural Mesothelioma”

The primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

Secondary endpoints are to evaluate: - the objective response rate (RR) of the combination; - the toxicity and the safety profile of the combination; - the duration of response (RD) and time to treatment failure (TTF); - the overall survival (OS) - RR, TTP and OS according to baseline plasma VEGF levels (introduced with Amendment 1 dated 8/11/2007)

Intervention(s) in this Clinical Trial

• Drug: Bevacizumab, Pemetrexed, Carboplatin
  • Bevacizumab: 15 mg/kg intravenous infusion over 30 to 90 minutes, following chemotherapy, on Day 1 every 3 weeks Pemetrexed: 500 mg/m2 intravenous infusion over 10 minutes on Day 1 every 3 weeks Carboplatin: AUC 5 intravenous infusion over 1 hour on Day 1 every 3 weeks

Primary Measures

• Time to progression (TTP) from first day of treatment until first observation of disease progression or death due to any cause or the last date the patient was known to be progression free or alive.
  • Time Frame: At the end of study
    Safety Issue?: No

Secondary Measures

• Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma.
  • Time Frame: Two months after the end of enrollment
    Safety Issue?: No
• Overall survival (OS) computed as the time between the first day of treatment and the date of death or the last date the patient was known to be alive.
  • Time Frame: At the end of study
    Safety Issue?: No

Inclusion Criteria:

• Histologically proven malignant pleural mesothelioma, inoperable, non previously treated with chemotherapy including intracavitary administration
• PS 0-1
• Measurable and/or evaluable lesions according to RECIST criteria
• Adequate organ function

Exclusion Criteria:

• Uncontrolled hypertension
• Evidence of bleeding diathesis or coagulopathy
• Pregnancy or breast-feeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Istituto Clinico Humanitas

Overall Clinical Trial Officials and Contacts

Armando Santoro, MD Principal Investigator Istituto Clinico Humanitas  

Overall Contact: Armando Santoro, MD +39 02 8224 armando.santoro@humanitas.it

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00407459

Study ID Number: ONC-2006-003

ClinicalTrials.gov Identifier: NCT00407459

Health Authority: Italy: Ministry of Health