Know Cancer

or
forgot password

Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Mesothelioma

Thank you

Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Outcome Description:

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

Outcome Time Frame:

Every 8 weeks until disease progression

Safety Issue:

No

Principal Investigator

Sai-Hong I. Ou, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000616162

NCT ID:

NCT00770120

Start Date:

December 2008

Completion Date:

June 2013

Related Keywords:

  • Malignant Mesothelioma
  • recurrent malignant mesothelioma
  • stage II malignant mesothelioma
  • stage III malignant mesothelioma
  • stage IV malignant mesothelioma
  • Mesothelioma

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