Spots Global Cancer Trial Database for S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
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Trial Identification
Brief Title: S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
Official Title: U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
Study ID: NCT00068367
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with unresectable or metastatic malignant peripheral nerve sheath tumor.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
University of California Davis Cancer Center, Davis, California, United States
Contra Costa Regional Medical Center, Martinez, California, United States
St. Anthony Central Hospital, Denver, Colorado, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado, United States
Montrose Memorial Hospital Cancer Center, Montrose, Colorado, United States
St. Anthony North Hospital, Westminster, Colorado, United States
Exempla Lutheran Medical Center, Wheat Ridge, Colorado, United States
Piedmont Hospital, Atlanta, Georgia, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
Northside Hospital Cancer Center, Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta, Atlanta, Georgia, United States
WellStar Cobb Hospital, Austell, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center, Decatur, Georgia, United States
Gwinnett Medical Center, Lawrenceville, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital, Marietta, Georgia, United States
Southern Regional Medical Center, Riverdale, Georgia, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States
St. Francis Hospital and Health Centers, Beech Grove, Indiana, United States
McFarland Clinic, P.C., Ames, Iowa, United States
Baton Rouge General Regional Cancer Center, Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans, New Orleans, Louisiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States
Mecosta County General Hospital, Big Rapids, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Mercy Medical Center, Grand Rapids, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus, Grand Rapids, Michigan, United States
Metropolitan Hospital, Grand Rapids, Michigan, United States
Spectrum Health Hospital - Blodgett Campus, Grand Rapids, Michigan, United States
Holland Community Hospital, Holland, Michigan, United States
Hackley Hospital, Muskegon, Michigan, United States
Northern Michigan Hospital, Petoskey, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Deaconess Billings Clinic - Downtown, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
St. Vincent Healthcare, Billings, Montana, United States
Deaconess Billings Clinic Cancer Center, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
St. James Community Hospital, Butte, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Eastern Montana Cancer Center, Miles City, Montana, United States
Community Medical Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Methodist Cancer Center at Methodist Hospital - Omaha, Omaha, Nebraska, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Wilson Medical Center, Wilson, North Carolina, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital, Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Community Oncology Group - Independence, Independence, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
Middletown Regional Hospital, Middletown, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Cleveland Clinic - Wooster, Wooster, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center, Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Institute of Oncology at Vilnius University, Portland, Oregon, United States
Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Legacy Meridian Park Hospital, Tualatin, Oregon, United States
Danville Regional Medical Center, Danville, Virginia, United States
Auburn Regional Center for Cancer Care, Auburn, Washington, United States
St. Joseph Hospital Community Cancer Center, Bellingham, Washington, United States
Olympic Hematology and Oncology, Bremerton, Washington, United States
Regional Cancer Center at Providence Hospital, Centralia, Washington, United States
St. Francis Hospital, Federal Way, Washington, United States
Skagit Valley Hospital Cancer Care Center, Mount Vernon, Washington, United States
Providence St. Peter Hospital Regional Cancer Center, Olympia, Washington, United States
Capital Medical Center, Olympia, Washington, United States
Good Samaritan Cancer Center, Puyallup, Washington, 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
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
North Puget Oncology at United General Hospital, Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Allenmore Hospital, Tacoma, Washington, United States
CCOP - Northwest, Tacoma, Washington, United States
St. Joseph Medical Center at Franciscan Health System, Tacoma, Washington, United States
St. Clare Hospital, Tacoma, Washington, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
Central Washington Hospital, Wenatchee, Washington, United States
Wenatchee Valley Clinic, Wenatchee, Washington, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital, Parkersburg, West Virginia, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Contact Details
Name: Karen H. Albritton, MD
Affiliation: Dana-Farber Cancer Institute
Role: STUDY_CHAIR
Name: R. Lor Randall, MD, FACS
Affiliation: University of Utah
Role: STUDY_CHAIR
Name: Scott M. Schuetze, MD, PhD
Affiliation: University of Michigan Rogel Cancer Center
Role: STUDY_CHAIR
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