Bortezomib and Cisplatin as First-Line Therapy in Treating Patients With Malignant Mesothelioma
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Bortezomib (VELCADE) With Cisplatin as First Line Treatment of Malignant Mesothelioma|
- Progression-free survival (PFS) rate at 18 weeks [ Designated as safety issue: No ]
- Overall objective response rate [ Designated as safety issue: No ]
- Symptomatic response rate [ Designated as safety issue: No ]
- Safety as measured by NCI CTCAE v3.0 and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire [ Designated as safety issue: Yes ]
- Duration of PFS [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||March 2012|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
- 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.
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Mary O'Brien, MD||Royal Marsden NHS Foundation Trust|