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

Primary Purpose

Mesothelioma

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Bevacizumab, Pemetrexed, Carboplatin
Sponsored by
Armando Santoro, MD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Clinico Humanitas

Outcomes

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.

Full Information

First Posted
December 4, 2006
Last Updated
August 31, 2011
Sponsor
Armando Santoro, MD
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1. Study Identification

Unique Protocol Identification Number
NCT00407459
Brief Title
Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma
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 Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Armando Santoro, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bevacizumab, Pemetrexed, Carboplatin
Other Intervention Name(s)
Avastin, Alimta, Carboplatin
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma.
Time Frame
Two months after the end of enrollment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
16549838
Citation
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. doi: 10.1200/JCO.2005.04.3190.
Results Reference
background
PubMed Identifier
17008700
Citation
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. doi: 10.1200/JCO.2006.06.8999.
Results Reference
background
PubMed Identifier
23860535
Citation
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.
Results Reference
derived

Learn more about this trial

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

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