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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00407459
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : September 2, 2011
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas

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

Condition or disease Intervention/treatment Phase
Mesothelioma Drug: Bevacizumab, Pemetrexed, Carboplatin Phase 2

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)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2007
Primary Completion Date : November 2010
Study Completion Date : November 2010

Intervention Details:
    Drug: 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
    Other Names:
    • Avastin
    • Alimta
    • Carboplatin

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma. [ Time Frame: Two months after the end of enrollment ]
  2. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00407459

Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Armando Santoro, MD
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas Identifier: NCT00407459     History of Changes
Other Study ID Numbers: ONC-2006-003
EUDRACT 2006-004429-27
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
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