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

NCT ID: NCT00407459

Last Updated: 2011-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-11-30

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)

Conditions

Mesothelioma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Avastin; Alimta; Carboplatin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Armando Santoro, MD

OTHER

Sponsor Role: lead

Responsible Party

Armando Santoro, MD

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Armando Santoro, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Countries

Italy

References

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. doi: 10.1200/JCO.2005.04.3190.

Reference Type: BACKGROUND

PMID: 16549838 (View on PubMed)

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. doi: 10.1200/JCO.2006.06.8999.

Reference Type: BACKGROUND

PMID: 17008700 (View on PubMed)

Ceresoli GL, Zucali PA, Mencoboni M, Botta M, Grossi F, Cortinovis D, Zilembo N, Ripa C, Tiseo M, Favaretto AG, Soto-Parra H, De Vincenzo F, Bruzzone A, Lorenzi E, Gianoncelli L, Ercoli B, Giordano L, Santoro A. Phase II study of pemetrexed and carboplatin plus bevacizumab as first-line therapy in malignant pleural mesothelioma. Br J Cancer. 2013 Aug 6;109(3):552-8. doi: 10.1038/bjc.2013.368. Epub 2013 Jul 16.

Reference Type: DERIVED

PMID: 23860535 (View on PubMed)

Other Identifiers

EUDRACT 2006-004429-27

Identifier Type: -

Identifier Source: secondary_id

ONC-2006-003

Identifier Type: -

Identifier Source: org_study_id