NCT00458913

Bortezomib and Cisplatin as First-Line Therapy in Treating Patients With Malignant Mesothelioma

Phase II Study of Bortezomib (VELCADE) With Cisplatin as First Line Treatment of Malignant Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with cisplatin may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with cisplatin works as first-line therapy in treating patients with malignant mesothelioma.

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. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive cisplatin IV over 1 hour on day 1 and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically. PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	bortezomib
DRUG	cisplatin

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-04-01
• Completion: 2012-03-01
• First posted: 2007-04-11
• Last updated: 2018-07-12

Locations

1 site across 1 country: United Kingdom