S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
NCT ID: NCT00068367
Last Updated: 2017-11-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2003-12-31
2009-08-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I (OSI-774)
Drug: erlotinib hydrochloride
Other Names:
OSI-774 150 mg per day, daily until disease progression
erlotinib hydrochloride
150 mg per day, daily until disease progression
Interventions
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erlotinib hydrochloride
150 mg per day, daily until disease progression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed malignant peripheral nerve sheath tumor
* Malignant schwannoma or neurofibrosarcoma
* Clinical evidence of unresectable or metastatic disease
* Measurable disease
* No known current CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT less than 1.5 times ULN (5 times ULN for patients with documented liver metastases)
Renal
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance greater than 60 mL/min
Ophthalmic
* No known history of any of the following corneal diseases:
* Dry eye syndrome
* Sjögren's syndrome
* Keratoconjunctivitis sicca
* Exposure keratopathy
* Fuch's dystrophy
* No other active disorders of the cornea
Gastrointestinal
* No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
* No active peptic ulcer disease
* No intractable nausea or vomiting
* Able to swallow medications OR receive enteral medications via gastrostomy feeding tube
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 28 days since prior biologic therapy for this malignancy
Chemotherapy
* More than 28 days since prior chemotherapy for this malignancy
Endocrine therapy
* Not specified
Radiotherapy
* More than 60 days since prior radiotherapy to the target lesion with subsequent documented progression
* More than 60 days since prior radiofrequency ablation to the target lesion with subsequent documented progression
* No concurrent radiotherapy
Surgery
* At least 3 weeks since prior major surgery and recovered
* No prior surgical procedure affecting absorption
Other
* More than 28 days since prior investigational drugs for this malignancy
* More than 60 days since prior embolization to the target lesion with subsequent documented progression
* No prior epidermal growth factor receptor-targeting therapy
* No concurrent antiretroviral therapy for HIV-positive patients
* No other concurrent investigational or commercial agents or therapies for the malignancy
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Karen H. Albritton, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
R. Lor Randall, MD, FACS
Role: STUDY_CHAIR
University of Utah
Scott M. Schuetze, MD, PhD
Role: STUDY_CHAIR
University of Michigan Rogel Cancer Center
Locations
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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
Countries
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References
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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.
Other Identifiers
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S0330
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000322023
Identifier Type: -
Identifier Source: org_study_id