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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00407459
First received: December 4, 2006
Last updated: August 31, 2011
Last verified: August 2011
  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:


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:
    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
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
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Neoplasms, Mesothelial
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pemetrexed
Bevacizumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014