S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
- Registration Number
- NCT00770120
- Lead Sponsor
- SWOG Cancer Research Network
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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.
Trial Locations
- Locations (129)
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Valley View Hospital Cancer Center
🇺🇸Glenwood Springs, Colorado, United States
Shaw Regional Cancer Center
🇺🇸Edwards, Colorado, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
Montrose Memorial Hospital Cancer Center
🇺🇸Montrose, Colorado, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
🇺🇸Marysville, California, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Edward Hospital Cancer Center
🇺🇸Naperville, Illinois, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Mary Rutan Hospital
🇺🇸Bellefontaine, Ohio, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Clackamas Radiation Oncology Center
🇺🇸Clackamas, Oregon, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States
Willamette Falls Hospital
🇺🇸Oregon City, Oregon, United States
U.T. Medical Center Cancer Institute
🇺🇸Knoxville, Tennessee, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Columbia Basin Hematology
🇺🇸Kennewick, Washington, United States
Providence Newberg Medical Center
🇺🇸Newberg, Oregon, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Evergreen Hematology and Oncology, PS
🇺🇸Spokane, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Northwest Cancer Specialists at Vancouver Cancer Center
🇺🇸Vancouver, Washington, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Valley Medical Oncology Consultants - Pleasanton
🇺🇸Pleasanton, California, United States
San Luis Valley Regional Medical Center
🇺🇸Alamosa, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Liberal
🇺🇸Liberal, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Wayne Hospital
🇺🇸Greenville, Ohio, United States
Knox Community Hospital
🇺🇸Mount Vernon, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health
🇺🇸Norton, Virginia, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mount Vernon, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Harrison Poulsbo Hematology and Onocology
🇺🇸Poulsbo, Washington, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Aurora, Colorado, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States