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

Sponsor
Armando Santoro, MD
Study ID
NCT00407459
Phase
PHASE2
Status
Completed

Conditions

  • Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab, Pemetrexed, Carboplatin — DRUG
    * 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

Study Details

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

Key Dates

First listed
Dec 5, 2006
Start date
Sep 30, 2007
Status verified
Aug 2011
Primary completion
Nov 30, 2010
Completion
Nov 30, 2010

Study Design

Enrollment
77 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

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 ]

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