S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring adult neurofibrosarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- University of California Davis Cancer Center
- Contra Costa Regional Medical Center
- St. Anthony Central Hospital
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Montrose Memorial Hospital Cancer Center
- St. Anthony North Hospital
- Exempla Lutheran Medical Center
- Piedmont Hospital
- CCOP - Atlanta Regional
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- WellStar Cobb Hospital
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Regional Cancer Center at Memorial Medical Center
- St. Francis Hospital and Health Centers
- McFarland Clinic, P.C.
- Baton Rouge General Regional Cancer Center
- Mary Bird Perkins Cancer Center - Baton Rouge
- MBCCOP - LSU Health Sciences Center
- Medical Center of Louisiana - New Orleans
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Mecosta County General Hospital
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Mercy Medical Center
- Spectrum Health Cancer Care - Butterworth Campus
- Metropolitan Hospital
- Spectrum Health Hospital - Blodgett Campus
- Holland Community Hospital
- Hackley Hospital
- Northern Michigan Hospital
- Munson Medical Center
- CCOP - Montana Cancer Consortium
- Deaconess Billings Clinic - Downtown
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- St. James Community Hospital
- St. Peter's Hospital
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Community Medical Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Methodist Cancer Center at Methodist Hospital - Omaha
- Blumenthal Cancer Center at Carolinas Medical Center
- Wayne Memorial Hospital, Incorporated
- Wilson Medical Center
- Cleveland Clinic Taussig Cancer Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Community Oncology Group - Independence
- Charles F. Kettering Memorial Hospital
- Middletown Regional Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Cleveland Clinic - Wooster
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Institute of Oncology at Vilnius University
- Cancer Institute at Oregon Health and Science University
- Legacy Meridian Park Hospital
- Danville Regional Medical Center
- Auburn Regional Center for Cancer Care
- St. Joseph Hospital Community Cancer Center
- Olympic Hematology and Oncology
- Regional Cancer Center at Providence Hospital
- St. Francis Hospital
- Skagit Valley Hospital Cancer Care Center
- Providence St. Peter Hospital Regional Cancer Center
- Capital Medical Center
- Good Samaritan Cancer Center
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Harborview Medical Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Allenmore Hospital
- CCOP - Northwest
- St. Joseph Medical Center at Franciscan Health System
- St. Clare Hospital
- Southwest Washington Medical Center Cancer Center
- Central Washington Hospital
- Wenatchee Valley Clinic
- Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
- Welch Cancer Center
Arms of the Study
Arm 1
Experimental
Arm I (OSI-774)
Drug: erlotinib hydrochloride Other Names: OSI-774 150 mg per day, daily until disease progression