Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma
Last Updated: August 28, 2007
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
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
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.
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.
- Histologically proven malignant pleural mesothelioma, inoperable, non previously treated with chemotherapy including intracavitary administration;
- measurable and/or evaluable lesions according to RECIST criteria;
- adequate organ function.
– 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 email@example.com
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.
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