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

Sponsor:	Istituto Clinico Humanitas
Information provided by:	Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:	NCT00407459

Purpose

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

Condition	Intervention	Phase
Mesothelioma	Drug: Bevacizumab, Pemetrexed, Carboplatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma

Resource links provided by NLM:

MedlinePlus related topics: Mesothelioma

Drug Information available for: Carboplatin Pemetrexed Pemetrexed disodium Bevacizumab

U.S. FDA Resources

Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma. [ Time Frame: Two months after the end of enrollment ] [ Designated as safety issue: No ]
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. [ Time Frame: At the end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	77
Study Start Date:	September 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407459

Contacts

Contact: Armando Santoro, MD	+39 02 8224 ext 4080	armando.santoro@humanitas.it
Contact: Paolo Andrea L Zucali, MD	+39 02 8224 ext 4559	paolo.zucali@humanitas.it

Locations

Italy, Milan
Istituto Clinico Humanitas	Recruiting
Rozzano, Milan, Italy, 20089
Contact: Armando Santoro, MD +39 02 8224 ext 4080 armando.santoro@humanitas.it
Contact: Paolo Andrea L Zucali, MD +39 02 8224 ext 4559 paolo.zucali@humanitas.it

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

Principal Investigator:

Armando Santoro, MD

Istituto Clinico Humanitas

More Information

Publications:

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.

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.

Responsible Party:	Istituto Clinico Humanitas ( Dr. Armando Santoro )
Study ID Numbers:	ONC-2006-003, EUDRACT 2006-004429-27
Study First Received:	December 4, 2006
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00407459 History of Changes
Health Authority:	Italy: Ministry of Health

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Bevacizumab
Carboplatin

Folic Acid Antagonists
Angiogenesis Inhibitors
Pharmacologic Actions
Pemetrexed
Neoplasms
Therapeutic Uses
Mesothelioma
Growth Inhibitors
Angiogenesis Modulating Agents
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009