Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma

Armando Santoro, MD77 enrolled

Overview

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

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mesothelioma

Interventions

Bevacizumab, Pemetrexed, CarboplatinDRUG

* 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Outcomes

Primary Outcomes

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

Secondary Outcomes

Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma.

Time frame: Two months after the end of enrollment

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

Data from ClinicalTrials.gov

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