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

Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407459
• Other study ID #: ONC-2006-003
• Secondary ID: EUDRACT 2006-004
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2006
• Last updated: August 31, 2011
• Start date: September 2007
• Est. completion date: November 2010

Study information

• Verified date: August 2011
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mesothelioma

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Armando Santoro, MD

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Ceresoli GL, Chiti A, Zucali PA, Rodari M, Lutman RF, Salamina S, Incarbone M, Alloisio M, Santoro A. Early response evaluation in malignant pleural mesothelioma by positron emission tomography with [18F]fluorodeoxyglucose. J Clin Oncol. 2006 Oct 1;24(28):4587-93. — View Citation

Ceresoli GL, Zucali PA, Favaretto AG, Grossi F, Bidoli P, Del Conte G, Ceribelli A, Bearz A, Morenghi E, Cavina R, Marangolo M, Parra HJ, Santoro A. Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma. J Clin Oncol. 2006 Mar 20;24(9):1443-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma.		Two months after the end of enrollment	No
Secondary	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	No