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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068367 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: erlotinib hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II |
| Study Start Date: | December 2003 |
OBJECTIVES:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant peripheral nerve sheath tumor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Ophthalmic
No known history of any of the following corneal diseases:
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Contra Costa Regional Medical Center | |
| Martinez, California, United States, 94553-3156 | |
| University of California Davis Cancer Center | |
| Davis, California, United States, 95616 | |
| United States, Colorado | |
| St. Anthony Central Hospital | |
| Denver, Colorado, United States, 80204 | |
| Montrose Memorial Hospital Cancer Center | |
| Montrose, Colorado, United States, 81401 | |
| Exempla Lutheran Medical Center | |
| Wheat Ridge, Colorado, United States, 80033 | |
| St. Anthony North Hospital | |
| Westminster, Colorado, United States, 80030 | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80217-3364 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342 | |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| Gwinnett Medical Center | |
| Lawrenceville, Georgia, United States, 30045 | |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | |
| Marietta, Georgia, United States, 30060 | |
| Northside Hospital Cancer Center | |
| Atlanta, Georgia, United States, 30342 | |
| Piedmont Hospital | |
| Atlanta, Georgia, United States, 30309 | |
| Saint Joseph's Hospital of Atlanta | |
| Atlanta, Georgia, United States, 30342 | |
| Southern Regional Medical Center | |
| Riverdale, Georgia, United States, 30274 | |
| WellStar Cobb Hospital | |
| Austell, Georgia, United States, 30106 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Regional Cancer Center at Memorial Medical Center | |
| Springfield, Illinois, United States, 62781-0001 | |
| United States, Indiana | |
| St. Francis Hospital and Health Centers | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Iowa | |
| McFarland Clinic, P.C. | |
| Ames, Iowa, United States, 50010 | |
| United States, Louisiana | |
| Baton Rouge General Regional Cancer Center | |
| Baton Rouge, Louisiana, United States, 70806 | |
| Mary Bird Perkins Cancer Center - Baton Rouge | |
| Baton Rouge, Louisiana, United States, 70809 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Medical Center of Louisiana - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Michigan | |
| Battle Creek Health System Cancer Care Center | |
| Battle Creek, Michigan, United States, 49017 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Hackley Hospital | |
| Muskegon, Michigan, United States, 49443 | |
| Holland Community Hospital | |
| Holland, Michigan, United States, 49423 | |
| Metropolitan Hospital | |
| Grand Rapids, Michigan, United States, 49506 | |
| Mecosta County General Hospital | |
| Big Rapids, Michigan, United States, 49307 | |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| Spectrum Health Cancer Care - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| Spectrum Health Hospital - Blodgett Campus | |
| Grand Rapids, Michigan, United States, 49506 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Montana | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Deaconess Billings Clinic - Downtown | |
| Billings, Montana, United States, 59101 | |
| Deaconess Billings Clinic Cancer Center | |
| Billings, Montana, United States, 59107 | |
| Eastern Montana Cancer Center | |
| Miles City, Montana, United States, 59301 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59802 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| St. James Community Hospital | |
| Butte, Montana, United States, 59701 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| St. Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Methodist Cancer Center at Methodist Hospital - Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| Wilson Medical Center | |
| Wilson, North Carolina, United States, 27893 | |
| United States, Ohio | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| Cleveland Clinic - Wooster | |
| Wooster, Ohio, United States, 44691 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| Community Oncology Group - Independence | |
| Independence, Ohio, United States, 44131 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| Institute of Oncology at Vilnius University | |
| Portland, Oregon, United States, 97227 | |
| Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center | |
| Portland, Oregon, United States, 97210 | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Legacy Meridian Park Hospital | |
| Tualatin, Oregon, United States, 97062 | |
| Legacy Mount Hood Medical Center | |
| Glesham, Oregon, United States, 97030 | |
| Providence Cancer Center at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| Providence Milwaukie Hospital | |
| Milwaukie, Oregon, United States, 97222 | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| United States, Virginia | |
| Danville Regional Medical Center | |
| Danville, Virginia, United States, 24541 | |
| United States, Washington | |
| Regional Cancer Center at Providence Hospital | |
| Centralia, Washington, United States, 98531 | |
| Allenmore Hospital | |
| Tacoma, Washington, United States, 98405 | |
| Auburn Regional Center for Cancer Care | |
| Auburn, Washington, United States, 98002 | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| Capital Medical Center | |
| Olympia, Washington, United States, 98507 | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405 | |
| Central Washington Hospital | |
| Wenatchee, Washington, United States, 98801 | |
| Olympic Hematology and Oncology | |
| Bremerton, Washington, United States, 98310 | |
| Good Samaritan Cancer Center | |
| Puyallup, Washington, United States, 98372 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98104 | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| North Puget Oncology at United General Hospital | |
| Sedro-Wooley, Washington, United States, 98284 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98104 | |
| Providence St. Peter Hospital Regional Cancer Center | |
| Olympia, Washington, United States, 95806 | |
| Skagit Valley Hospital Cancer Care Center | |
| Mt. Vernon, Washington, United States, 98273 | |
| Southwest Washington Medical Center Cancer Center | |
| Vancouver, Washington, United States, 98668 | |
| St. Clare Hospital | |
| Tacoma, Washington, United States, 98499 | |
| St. Francis Hospital | |
| Federal Way, Washington, United States, 98003 | |
| St. Joseph Hospital Community Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| St. Joseph Medical Center at Franciscan Health System | |
| Tacoma, Washington, United States, 98405 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98114 | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| Wenatchee Valley Clinic | |
| Wenatchee, Washington, United States, 98801 | |
| United States, West Virginia | |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | |
| Parkersburg, West Virginia, United States, 26101 | |
| United States, Wyoming | |
| Welch Cancer Center | |
| Sheridan, Wyoming, United States, 82801 | |
| Investigator: | Karen H. Albritton, MD | Dana-Farber Cancer Institute |
| Investigator: | R. Lor Randall, MD, FACS | University of Utah |
| Investigator: | Scott M. Schuetze, MD, PhD | University of Michigan Cancer Center |
More Information
| Study ID Numbers: | CDR0000322023, SWOG-S0330 |
| Study First Received: | September 10, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068367 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Erlotinib Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Nerve Tissue Nervous System Diseases Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Neoplasms, Connective and Soft Tissue Neoplasms Neuromuscular Diseases Peripheral Nervous System Diseases Sarcoma Peripheral Nervous System Neoplasms Nerve Sheath Neoplasms Nervous System Neoplasms |