Clinical Trial for Mesothelioma Patients: Bortezomib and Cisplatin Study Criteria

Read about the study criteria for a current clinical trial being conducted to study the effects of Bortezomib and Cisplatin for patients who have been diagnosed with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only. This study is being conducted ONLY in the United Kingdom.

Study Phase, Type and Design: Interventional; Treatment, Non Randomized, Open Label

Primary Outcome Measures:

• Progression-free survival (PFS) rate at 18 weeks

Secondary Outcome Measures:

• Overall objective response rate
• Symptomatic response rate
• Safety as measured by NCI CTCAE v3.0 and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire
• Duration of PFS
• Overall survival

Recruitment Information:

Recruitment status: Recruiting
Enrollment: 76
Start Date: February 2007
Ending Date: December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:
• Determine the activity and safety of Bortezomib and Cisplatin as first-line treatment in patients with malignant mesothelioma.
• Validate the use of progression-free survival rate as a primary endpoint for the design of phase II mesothelioma trials.

Disease Characteristics:

• Histologically confirmed pleural malignant mesothelioma, meeting 1 of the following criteria:
o Recurrent disease after radical surgery
o Disease not considered suitable for radical treatment
• Measurable or evaluable disease
• No clinical evidence of brain or leptomeningeal metastases

Courtesy of ClinicalTrials.gov, a service of the U.S. National Institutes of Health

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