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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00770120
Other study ID # CDR0000616162
Secondary ID S0722U10CA032102
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2008
Est. completion date April 2014

Study information

Verified date February 2020
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 61
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
everolimus


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Garland LL, Ou SH, Moon J, et al.: SWOG 0722: A phase II study of mTOR inhibitor everolimus (RAD001) in malignant pleural mesothelioma (MPM). [Abstract] J Clin Oncol 30 (Suppl 15): A-7083, 2012.

Outcome

Type Measure Description Time frame Safety issue
Primary 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, up to 3 years.
Secondary Response 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. Every 8 weeks until disease progression, up to 3 years.
Secondary Overall Survival 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. Every 8 weeks until disease progression, up to 3 years.
Secondary 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.
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