S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
3 other identifiers
interventional
24
1 country
101
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2003
Longer than P75 for phase_2
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2003
CompletedFirst Posted
Study publicly available on registry
September 11, 2003
CompletedStudy Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
November 6, 2017
CompletedNovember 6, 2017
October 1, 2017
3.6 years
September 10, 2003
April 20, 2017
October 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.
Complete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions.
25 weeks
Secondary Outcomes (1)
Toxicity
Up to 25 weeks
Other Outcomes (2)
Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug.
Feasibility of Accruing These Patients in the Cooperative Group Setting
Study Arms (1)
Arm I (OSI-774)
EXPERIMENTALDrug: erlotinib hydrochloride Other Names: OSI-774 150 mg per day, daily until disease progression
Interventions
150 mg per day, daily until disease progression
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- SWOG Cancer Research Networklead
- National Cancer Institute (NCI)collaborator
Study Sites (101)
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
University of California Davis Cancer Center
Davis, California, 95616, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
St. Anthony Central Hospital
Denver, Colorado, 80204, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80217-3364, United States
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, 81401, United States
St. Anthony North Hospital
Westminster, Colorado, 80030, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342, United States
Northside Hospital Cancer Center
Atlanta, Georgia, 30342, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
WellStar Cobb Hospital
Austell, Georgia, 30106, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, 30033, United States
Gwinnett Medical Center
Lawrenceville, Georgia, 30045, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Southern Regional Medical Center
Riverdale, Georgia, 30274, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
St. Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
McFarland Clinic, P.C.
Ames, Iowa, 50010, United States
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, 70806, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, 70112, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, 49017, United States
Mecosta County General Hospital
Big Rapids, Michigan, 49307, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Mercy Medical Center
Grand Rapids, Michigan, 49503, United States
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Metropolitan Hospital
Grand Rapids, Michigan, 49506, United States
Spectrum Health Hospital - Blodgett Campus
Grand Rapids, Michigan, 49506, United States
Holland Community Hospital
Holland, Michigan, 49423, United States
Hackley Hospital
Muskegon, Michigan, 49443, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
St. Vincent Healthcare
Billings, Montana, 59101, United States
Deaconess Billings Clinic Cancer Center
Billings, Montana, 59107, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
St. James Community Hospital
Butte, Montana, 59701, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Eastern Montana Cancer Center
Miles City, Montana, 59301, United States
Community Medical Center
Missoula, Montana, 59801, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59802, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, 68114, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Wilson Medical Center
Wilson, North Carolina, 27893, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428, United States
CCOP - Dayton
Dayton, Ohio, 45429, United States
Community Oncology Group - Independence
Independence, Ohio, 44131, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
Middletown Regional Hospital
Middletown, Ohio, 45044, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373, United States
Cleveland Clinic - Wooster
Wooster, Ohio, 44691, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
Portland, Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Institute of Oncology at Vilnius University
Portland, Oregon, 97227, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Auburn Regional Center for Cancer Care
Auburn, Washington, 98002, United States
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton, Washington, 98310, United States
Regional Cancer Center at Providence Hospital
Centralia, Washington, 98531, United States
St. Francis Hospital
Federal Way, Washington, 98003, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, 98273, United States
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, 95806, United States
Capital Medical Center
Olympia, Washington, 98507, United States
Good Samaritan Cancer Center
Puyallup, Washington, 98372, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98104, United States
Group Health Central Hospital
Seattle, Washington, 98104, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98114, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195, United States
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Allenmore Hospital
Tacoma, Washington, 98405, United States
CCOP - Northwest
Tacoma, Washington, 98405, United States
St. Joseph Medical Center at Franciscan Health System
Tacoma, Washington, 98405, United States
St. Clare Hospital
Tacoma, Washington, 98499, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98668, United States
Central Washington Hospital
Wenatchee, Washington, 98801, United States
Wenatchee Valley Clinic
Wenatchee, Washington, 98801, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26101, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Albritton KH, Rankin C, Coffin CM, et al.: Phase II study of erlotinib in metastatic or unresectable malignant peripheral nerve sheath tumors (MPNST). [Abstract] J Clin Oncol 24 (Suppl 18): A-9518, 524s, 2006.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- SWOG Statistical Center
Study Officials
- STUDY CHAIR
Karen H. Albritton, MD
Dana-Farber Cancer Institute
- STUDY CHAIR
R. Lor Randall, MD, FACS
University of Utah
- STUDY CHAIR
Scott M. Schuetze, MD, PhD
University of Michigan Rogel Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2003
First Posted
September 11, 2003
Study Start
December 1, 2003
Primary Completion
July 1, 2007
Study Completion
August 1, 2009
Last Updated
November 6, 2017
Results First Posted
November 6, 2017
Record last verified: 2017-10