NCT00770120

S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery

Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with pleural malignant mesothelioma that cannot be removed by surgery.

Detailed description

OBJECTIVES: Primary * To determine the 4-month progression-free survival in patients with unresectable malignant pleural mesothelioma treated with everolimus. Secondary * To determine the response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate (response or stable disease) in patients with measurable disease by RECIST and modified RECIST criteria. * To determine overall survival of these patients. * To evaluate the frequency and severity of toxicities associated with this treatment regimen. OUTLINE: This is a multicenter study. Patients receive oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 3 years.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	everolimus

Timeline

• Start date: 2008-12-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2008-10-09
• Last updated: 2020-03-06
• Results posted: 2017-03-01

Locations

129 sites across 1 country: United States