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

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Everolimus	everolimus	Daily oral Everolimus 10 mg/day

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	Every 8 weeks until disease progression, up to 3 years.	Progression-Free Survival was defined as the duration from the date of registration until the date of disease progression per RECIST or death due to any cause. Patients known to be alive without evidence of disease progression were censored at the date of last contact. Disease progression was defined as a \>= 20% increase over nadir in the sum of longest diameters of target lesions, unequivocal progression of non-target lesions in the opinion of the treating investigator, appearance of new lesions, symptomatic deterioration, or death due to disease

Secondary Outcome Measures

Name	Time	Method
Response	Every 8 weeks until disease progression, up to 3 years.	A response was defined as either a confirmed or unconfirmed complete or partial responses as defined by RECIST. A complete response (CR) was defined as the disappearance of all disease. A partial response (PR) was defined as a \>= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was considered confirmed if two consecutive determinations were made at least 4 weeks apart.
Overall Survival	Every 8 weeks until disease progression, up to 3 years.	Overall survival was defined as the duration between the date of enrollment and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
Frequency and Severity of Toxicities	Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter.

Locations (129): Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸
Tucson, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸
Los Angeles, California, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
🇺🇸
Marysville, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸
Orange, California, United States
Valley Medical Oncology Consultants - Pleasanton
🇺🇸
Pleasanton, California, United States
University of California Davis Cancer Center
🇺🇸
Sacramento, California, United States
San Luis Valley Regional Medical Center
🇺🇸
Alamosa, Colorado, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸
Aurora, Colorado, United States
Shaw Regional Cancer Center
🇺🇸
Edwards, Colorado, United States
Valley View Hospital Cancer Center
🇺🇸
Glenwood Springs, Colorado, United States
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Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States