U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
OBJECTIVES:
- Determine response (confirmed, complete, and partial) in patients with unresectable or
metastatic malignant peripheral nerve sheath tumor when treated with erlotinib.
- Determine the qualitative and quantitative toxic effects of this drug in these
patients.
- Correlate, preliminarily, indicators of epidermal growth factor receptor (EGFR)
function (e.g., expression, phosphorylation, or markers of signal transduction
downstream of EGFR) with response and progression-free and overall survival in patients
treated with this drug.
- Determine the feasibility of accruing these patients in the cooperative group setting.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Patients who achieve at least a confirmed partial response and become resectable undergo
surgical resection (with or without radiotherapy) and then receive 2 additional courses of
erlotinib. Patients with responding disease who do not become resectable continue erlotinib
as above. Patients achieving a complete response (CR) receive 2 additional courses of
erlotinib beyond the CR.
Patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response as assessed by RECIST radiographic criteria
x-rays and scans
every eight weeks during treatment
No
Karen H. Albritton, MD
Study Chair
Dana-Farber Cancer Institute
United States: Federal Government
CDR0000322023
NCT00068367
December 2003
August 2009
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
Spectrum Health Cancer Care - Butterworth Campus | Grand Rapids, Michigan 49503-2560 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Mecosta County General Hospital | Big Rapids, Michigan 49307 |
Metropolitan Hospital | Grand Rapids, Michigan 49506 |
Lacks Cancer Center at Saint Mary's Mercy Medical Center | Grand Rapids, Michigan 49503 |
Holland Community Hospital | Holland, Michigan 49423 |
Hackley Hospital | Muskegon, Michigan 49443 |
Northern Michigan Hospital | Petoskey, Michigan 49770 |
Munson Medical Center | Traverse City, Michigan 49684 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Deaconess Billings Clinic Cancer Center | Billings, Montana 59107 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
St. James Community Hospital | Butte, Montana 59701 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Eastern Montana Cancer Center | Miles City, Montana 59301 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
St. Joseph Hospital Community Cancer Center | Bellingham, Washington 98225 |
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 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Central Washington Hospital | Wenatchee, Washington 98801 |
Wenatchee Valley Clinic | Wenatchee, Washington 98801 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
Piedmont Hospital | Atlanta, Georgia 30309 |
WellStar Cobb Hospital | Austell, Georgia 30106 |
Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70112 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
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 |
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 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
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 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
St. Anthony North Hospital | Westminster, Colorado 80030 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Baton Rouge General Regional Cancer Center | Baton Rouge, Louisiana 70821 |
Community Oncology Group - Independence | Independence, Ohio 44131 |
St. Francis Hospital | Federal Way, Washington 98003 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Capital Medical Center | Olympia, Washington 98502 |
Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
St. Joseph Medical Center at Franciscan Health System | Tacoma, Washington 98405-3004 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
McFarland Clinic, P.C. | Ames, Iowa 50010 |
St. Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Spectrum Health Hospital - Blodgett Campus | Grand Rapids, Michigan 49506 |
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center | Portland, Oregon 97210 |
Institute of Oncology at Vilnius University | Portland, Oregon 97227 |
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Auburn Regional Center for Cancer Care | Auburn, Washington 98002 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Regional Cancer Center at Providence Hospital | Centralia, Washington 98531 |