Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma
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ClinicalTrials.gov Identifier: NCT00407459 |
Recruitment Status :
Completed
First Posted : December 5, 2006
Last Update Posted : September 2, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mesothelioma | Drug: Bevacizumab, Pemetrexed, Carboplatin | Phase 2 |
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)
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 77 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |

- Drug: Bevacizumab, Pemetrexed, Carboplatin
- 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
- 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 ]
- Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma. [ Time Frame: 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. [ Time Frame: At the end of study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407459
Italy | |
Istituto Clinico Humanitas | |
Rozzano, Milan, Italy, 20089 |
Principal Investigator: | Armando Santoro, MD | Istituto Clinico Humanitas |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Armando Santoro, MD, MD, Istituto Clinico Humanitas |
ClinicalTrials.gov Identifier: | NCT00407459 |
Other Study ID Numbers: |
ONC-2006-003 EUDRACT 2006-004429-27 |
First Posted: | December 5, 2006 Key Record Dates |
Last Update Posted: | September 2, 2011 |
Last Verified: | August 2011 |
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Bevacizumab Carboplatin Pemetrexed Antineoplastic Agents, Immunological |
Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |