| December 4, 2006 |
| August 27, 2009 |
| September 2007 |
| September 2008 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: No ] |
| 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. |
| Complete list of historical versions of study NCT00407459 on ClinicalTrials.gov Archive Site |
- Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma. [ Time Frame: Two months after the end of enrollment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|
- 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.
|
| |
| Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma |
| Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With 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. |
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)
|
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Mesothelioma |
| Drug: Bevacizumab, Pemetrexed, Carboplatin |
| |
- 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.
|
| |
| Recruiting |
| 77 |
| June 2009 |
| September 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
|
|
| Italy |
| |
| NCT00407459 |
| Dr. Armando Santoro, Istituto Clinico Humanitas |
| ONC-2006-003, EUDRACT 2006-004429-27 |
| Istituto Clinico Humanitas |
|
| Principal Investigator: |
Armando Santoro, MD |
Istituto Clinico Humanitas |
|
|
| Istituto Clinico Humanitas |
| August 2009 |
