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

Phase 2

Completed

• Conditions: Malignant Mesothelioma

• Registration Number: NCT00458913
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-04-09
• Study First Submitted QC: 2007-04-09
• Study First Posted: 2007-04-11
• Primary Completion: 2010-04
• Study Completion: 2012-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) rate at 18 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Marsden - Surrey; 🇬🇧 Sutton, England, United Kingdom