NCT00407459CompletedPhase 2
Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma
Armando Santoro, MD2 sites in 1 country77 target enrollmentStarted: September 1, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 77
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
Brief Summary
The primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically proven malignant pleural mesothelioma, inoperable, non previously treated with chemotherapy including intracavitary administration
- •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
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.(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.(At the end of study)
Investigators
Armando Santoro, MD
MD
Istituto Clinico Humanitas
Study Sites (2)
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