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

Sponsor:	Armando Santoro, MD
Information provided by (Responsible Party):	Armando Santoro, MD, 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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 ]

Enrollment:	77
Study Start Date:	September 2007
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (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

Other Names:

Avastin
Alimta
Carboplatin

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

Locations

Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089

Sponsors and Collaborators

Armando Santoro, MD

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:	Armando Santoro, MD, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:	NCT00407459 History of Changes
Other Study ID Numbers:	ONC-2006-003, EUDRACT 2006-004429-27
Study First Received:	December 4, 2006
Last Updated:	August 31, 2011
Health Authority:	Italy: Ministry of Health

Additional relevant MeSH terms:

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pemetrexed
Bevacizumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012