S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
Malignant Mesothelioma
About this trial
This is an interventional treatment trial for Malignant Mesothelioma focused on measuring recurrent malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma, stage IV malignant mesothelioma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural mesothelioma
- Unresectable disease
- Must have measurable or nonmeasurable disease by RECIST or modified RECIST criteria
Must have received prior systemically administered* platinum-based chemotherapy and meets the following criteria:
- No more than 2 prior systemic therapeutic regimens allowed (including biologics, targeted, and immunotherapies)
- At least 1 regimen must have been platinum-based
- Neoadjuvant and/or adjuvant systemic therapy is not counted as a prior regimen, assuming ≥ 12 weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease NOTE: *Pleural space washing with cisplatin does not constitute systemic administration
- No known CNS metastases
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Serum bilirubin normal
- AST or ALT ≤ 1.5 times upper limit of normal (ULN)
- Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
No evidence of bleeding diathesis or coagulopathy
Previous pulmonary embolism allowed provided the patient is on therapeutic low molecular weight heparin injections or warfarin AND no evidence of bleeding
- Patients on therapeutic warfarin must have an INR of < 5 within 28 days prior to registration
- No pathologic condition other than mesothelioma that carries a high risk of bleeding
- No known HIV positivity
- No gastrointestinal tract disease resulting in an inability to take oral or enteral medication via a feeding tube or a requirement for IV alimentation, or active peptic ulcer disease
No other prior malignancy allowed except for any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer from which the patient is currently in complete remission
- Any other cancer from which patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- At least 28 days since prior systemic therapy (42 days for nitrosoureas or mitomycin C)
- At least 28 days since prior thoracic or other major surgery (e.g., pleurectomy or pleurodesis) and no anticipated need for major surgical procedures during study
- At least 14 days since prior radiotherapy
- No prior surgical procedure affecting absorption
No prior chronic, systemic corticosteroids or other immunosuppressive agent, except corticosteroids equivalent to prednisone ≤ 20 mg daily
- Must have been on a stable dosage regimen for ≥ 4 weeks
- Topical and inhaled corticosteroids allowed
- No prior mTOR inhibitor therapy (i.e., rapamycin, everolimus, or temsirolimus)
- No concurrent immunization with attenuated live vaccines
- No concurrent antiretroviral therapy for HIV-positive patients
- No other concurrent investigational therapy
- No other concurrent anticancer agents
Sites / Locations
- Arizona Cancer Center at University of Arizona Health Sciences Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- Valley Medical Oncology Consultants - Pleasanton
- University of California Davis Cancer Center
- San Luis Valley Regional Medical Center
- University of Colorado Cancer Center at UC Health Sciences Center
- Shaw Regional Cancer Center
- Valley View Hospital Cancer Center
- Montrose Memorial Hospital Cancer Center
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Northeast Georgia Medical Center
- Decatur Memorial Hospital Cancer Care Institute
- Edward Hospital Cancer Center
- Regional Cancer Center at Memorial Medical Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Reid Hospital & Health Care Services
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Barbara Ann Karmanos Cancer Institute
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Memorial Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- St. John Macomb Hospital
- CCOP - Montana Cancer Consortium
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- University of New Mexico Cancer Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Wayne Memorial Hospital, Incorporated
- Iredell Memorial Hospital
- Mary Rutan Hospital
- Adena Regional Medical Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Grady Memorial Hospital
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Knox Community Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Community Hospital of Springfield and Clark County
- UVMC Cancer Care Center at Upper Valley Medical Center
- Mount Carmel St. Ann's Cancer Center
- Clinton Memorial Hospital
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Clackamas Radiation Oncology Center
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Willamette Falls Hospital
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- U.T. Medical Center Cancer Institute
- M. D. Anderson Cancer Center at University of Texas
- Danville Regional Medical Center
- Southwest Virginia Regional Cancer Center at Wellmonth Health
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Columbia Basin Hematology
- Skagit Valley Hospital Cancer Care Center
- Harrison Poulsbo Hematology and Onocology
- Harborview Medical Center
- Minor and James Medical, PLLC
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology, PS
- Southwest Washington Medical Center Cancer Center
- Northwest Cancer Specialists at Vancouver Cancer Center
- Wenatchee Valley Medical Center
- Rocky Mountain Oncology
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
Everolimus
Daily oral Everolimus 10 mg/day