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Completed

NCT Number: NCT00407459

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

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

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Key information

Conditions

Mesothelioma Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab, Pemetrexed, Carboplatin

Drug
  • 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 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.

    Time frame: At the end of study

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Armando Santoro, MD

Other

Registry information

Official study title

Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 5, 2006
Registry last updated
Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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