Date First Received: December 4, 2006

Last Updated: August 28, 2007

Rationale

Official Title: "Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-Line Therapy in Patients With Malignant Pleural Mesothelioma"

Condition Keyword(s): Mesothelioma

Intervention(s):

Drug: bevacizumab
Drug: pemetrexed
Drug: carboplatin

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Detailed Clinical Trial Description

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

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)

Outcome Measures for this Clinical Trial

Primary
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
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.

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.

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Istituto Clinico Humanitas

Istituto Clinico Humanitas

Rozzano Milan 20089 Italy

Overall Clinical Trial Officials and Contacts

Armando Santoro, MD Principal Investigator Istituto Clinico Humanitas

Overall Contact: Armando Santoro, MD +39 02 8224 armando.santoro@humanitas.it

References

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.

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.

Additional Information

Information obtained from ClinicalTrials.gov on April 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00407459

Study ID Number: ONC-2006-003

ClinicalTrials.gov Identifier: NCT00407459

Labels: ClinicalTrial