Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma

• ClinicalTrials.gov Identifier: NCT00407459
• Recruitment Status: Completed
• First Posted: December 5, 2006
• Last Update Posted: September 2, 2011
• Sponsor: Armando Santoro, MD
• Information provided by (Responsible Party): Armando Santoro, MD, Istituto Clinico Humanitas

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Mesothelioma	Drug: Bevacizumab, Pemetrexed, Carboplatin	Phase 2

Detailed 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)

Study Design

• 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

Arms and Interventions

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma. [ Time Frame: Two months after the end of enrollment ]
2. 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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Italy

Istituto Clinico Humanitas

Rozzano, Milan, Italy, 20089

Sponsors and Collaborators

Armando Santoro, MD

Investigators

• Principal Investigator: Armando Santoro, MD; Istituto Clinico Humanitas

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ceresoli GL, Zucali PA, Mencoboni M, Botta M, Grossi F, Cortinovis D, Zilembo N, Ripa C, Tiseo M, Favaretto AG, Soto-Parra H, De Vincenzo F, Bruzzone A, Lorenzi E, Gianoncelli L, Ercoli B, Giordano L, Santoro A. Phase II study of pemetrexed and carboplatin plus bevacizumab as first-line therapy in malignant pleural mesothelioma. Br J Cancer. 2013 Aug 6;109(3):552-8. doi: 10.1038/bjc.2013.368. Epub 2013 Jul 16.

• 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
• Last Update Posted: September 2, 2011
• Last Verified: August 2011

Additional relevant MeSH terms:

Mesothelioma; Mesothelioma, Malignant; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; 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