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Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma


Phase 2
18 Years
N/A
Not Enrolling
Both
Mesothelioma

Thank you

Trial Information

Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma


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)


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

Type of Study:

Interventional

Study Design:

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

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.

Outcome Time Frame:

At the end of study

Safety Issue:

No

Principal Investigator

Armando Santoro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Clinico Humanitas

Authority:

Italy: Ministry of Health

Study ID:

ONC-2006-003

NCT ID:

NCT00407459

Start Date:

September 2007

Completion Date:

November 2010

Related Keywords:

  • Mesothelioma
  • Mesothelioma

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