NCT00407459

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

September 2, 2011

Status Verified

August 1, 2011

Enrollment Period

3.2 years

First QC Date

December 4, 2006

Last Update Submit

August 31, 2011

Conditions

Mesothelioma

Outcome Measures

Primary Outcomes (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.

    At the end of study

Secondary Outcomes (2)

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

    Two months after the end of enrollment

  • 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.

    At the end of study

Interventions

Bevacizumab, Pemetrexed, CarboplatinDRUG

* 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

Also known as: Avastin, Alimta, Carboplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Uncontrolled hypertension
  • Evidence of bleeding diathesis or coagulopathy
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

Related Publications (3)

  • 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.

    PMID: 16549838BACKGROUND

  • 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.

    PMID: 17008700BACKGROUND

  • 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.

    PMID: 23860535DERIVED

MeSH Terms

Conditions

Mesothelioma

Interventions

BevacizumabPemetrexedCarboplatin

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, DicarboxylicCoordination ComplexesOrganic Chemicals

Study Officials

  • Armando Santoro, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 5, 2006

Study Start

September 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 2, 2011

Record last verified: 2011-08

Locations

IT(1)