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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Current Primary Outcome: Progression-free survival (PFS) rate at 18 weeks

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: European Organisation for Research and Treatment of Cancer - EORTC

Dates:
Date Received: April 9, 2007
Date Started: February 2007
Date Completion:
Last Updated: April 19, 2013
Last Verified: April 2013