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

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 2


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

Genetic and Rare Diseases Information Center resources: Malignant Mesothelioma

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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 Bevacizumab Pemetrexed Carboplatin Angiogenesis Inhibitors	Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016