S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)|
- Progression-Free Survival [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]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
- Response [ Time Frame: Every 8 weeks while on protocol treatment. ] [ Designated as safety issue: No ]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 [ Time Frame: Weekly during the first 8 weeks of treatment, then every 3 weeks while on treatment, then every 8 weeks until disease porgression, then every 6 months thereafter. ] [ Designated as safety issue: No ]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 [ Time Frame: From date of registration to 3 years post registration or death (whichever occurs first) ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Daily oral Everolimus 10 mg/day
- To determine the 4-month progression-free survival in patients with unresectable malignant pleural mesothelioma treated with everolimus.
- 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.
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|Study Chair:||Sai-Hong I. Ou, MD, PhD||Chao Family Comprehensive Cancer Center|
|Study Chair:||Linda Garland, MD||University of Arizona|