Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival
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
Every 8 weeks until disease progression
No
Sai-Hong I. Ou, MD, PhD
Study Chair
Chao Family Comprehensive Cancer Center
United States: Federal Government
CDR0000616162
NCT00770120
December 2008
June 2013
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Edward Hospital Cancer Center | Naperville, Illinois 60540 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Northern Montana Hospital | Havre, Montana 59501 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton, Virginia 24273 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Columbia Basin Hematology | Kennewick, Washington 99336 |
Harrison Poulsbo Hematology and Onocology | Poulsbo, Washington 98370 |
Evergreen Hematology and Oncology, PS | Spokane, Washington 99218 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Tibotec Therapeutics - Division of Ortho Biotech Products, LP | Marysville, California 95901 |
Valley Medical Oncology Consultants - Pleasanton | Pleasanton, California 94588 |
U.T. Medical Center Cancer Institute | Knoxville, Tennessee 37920-6999 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver, Washington 98684 |
Shaw Regional Cancer Center | Edwards, Colorado 81632 |
San Luis Valley Regional Medical Center | Alamosa, Colorado 81101 |
Valley View Hospital Cancer Center | Glenwood Springs, Colorado 81601 |
Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
Providence Newberg Medical Center | Newberg, Oregon 97132 |
Willamette Falls Hospital | Oregon City, Oregon 97045 |