Phase II Study of Bortezomib (VELCADE) With Cisplatin as First Line Treatment of Malignant Mesothelioma
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) rate at 18 weeks
Mary O'Brien, MD
Royal Marsden NHS Foundation Trust
United States: Federal Government