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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00407459
Other study ID # ONC-2006-003
Secondary ID EUDRACT 2006-004
Status Completed
Phase Phase 2
First received December 4, 2006
Last updated August 31, 2011
Start date September 2007
Est. completion date November 2010

Study information

Verified date August 2011
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Description:

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)


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Istituto Clinico Humanitas Rozzano Milan

Sponsors (1)

Lead Sponsor Collaborator
Armando Santoro, MD

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. At the end of study No
Secondary Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma. Two months after the end of enrollment No
Secondary 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. At the end of study No
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