Mesothelioma Related Clinical Trials:
Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-Line Therapy in Patients With Malignant Pleural Mesothelioma

In Page Navigation: - General Info - Purpose - Eligibility - Contacts & Locations - Additional Information

   

Status: Not_yet
Sponsors and Collaborators: Istituto Clinico Humanitas
Information provided by: Istituto Clinico Humanitas
Government Identifier: NCT00407459

Condition: Mesothelioma
Intervention: Drug: bevacizumab; Drug: pemetrexed; Drug: carboplatin

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Purpose:


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

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

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.

Secondary Outcome Measures:
  • Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma.
  • 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.

Estimated Enrollment:   77

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)

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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.

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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: Giovanni L Ceresoli, MD     +39 02 8224 ext 4559     giovanni_luca.ceresoli@humanitas.it    
Locations
Italy, Milan
Istituto Clinico Humanitas     Not yet recruiting
      Rozzano, Milan, Italy, 20089
      Contact: Armando Santoro, MD     +39 02 8224 ext 4080    armando.santoro@humanitas.it   

Sponsors and Collaborators
Istituto Clinico Humanitas

Investigators
Principal Investigator:     Armando Santoro, MD     Istituto Clinico Humanitas    

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Additional 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.
 

Study ID Numbers:   ONC-2006-003, EUDRACT 2006-004429-27
First Received:   December 4, 2006
Last Updated:   August 28, 2007
ClinicalTrials.gov Identifier:   NCT00407459
Health Authority:   Italy: Ministry of Health

Study placed in the following topic categories:
Folic Acid
Pemetrexed
Mesothelioma
Carboplatin
Bevacizumab
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Mesothelioma
Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

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