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

Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00407459

Enrollment

Registered

2006-12-05

Start date

2007-09-30

Completion date

2010-11-30

Last updated

2011-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesothelioma

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)

Interventions

DRUGBevacizumab, 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	At the end of study

Secondary

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026