S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
This study has been completed.
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00068367
First received: September 10, 2003
Last updated: January 13, 2012
Last verified: January 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II |
Resource links provided by NLM:
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Tumor response as assessed by RECIST radiographic criteria [ Time Frame: every eight weeks during treatment ] [ Designated as safety issue: No ]x-rays and scans
Secondary Outcome Measures:
- Toxicity as assessed by CTCAE [ Time Frame: every two weeks for two cycles and then every four weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 24 |
| Study Start Date: | December 2003 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: erlotinib hydrochloride
150 mg per day, daily until disease progression
Other Name: OSI-774
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068367
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| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| University of California Davis Cancer Center | |
| Davis, California, United States, 95616 | |
| Contra Costa Regional Medical Center | |
| Martinez, California, United States, 94553-3156 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80217-3364 | |
| St. Anthony Central Hospital | |
| Denver, Colorado, United States, 80204 | |
| Montrose Memorial Hospital Cancer Center | |
| Montrose, Colorado, United States, 81401 | |
| St. Anthony North Hospital | |
| Westminster, Colorado, United States, 80030 | |
| Exempla Lutheran Medical Center | |
| Wheat Ridge, Colorado, United States, 80033 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342 | |
| Piedmont Hospital | |
| Atlanta, Georgia, United States, 30309 | |
| Northside Hospital Cancer Center | |
| Atlanta, Georgia, United States, 30342 | |
| Saint Joseph's Hospital of Atlanta | |
| Atlanta, Georgia, United States, 30342 | |
| WellStar Cobb Hospital | |
| Austell, Georgia, United States, 30106 | |
| 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 | |
| Southern Regional Medical Center | |
| Riverdale, Georgia, United States, 30274 | |
| 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 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| Battle Creek Health System Cancer Care Center | |
| Battle Creek, Michigan, United States, 49017 | |
| Mecosta County General Hospital | |
| Big Rapids, Michigan, United States, 49307 | |
| Metropolitan Hospital | |
| Grand Rapids, Michigan, United States, 49506 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Spectrum Health Hospital - Blodgett Campus | |
| Grand Rapids, Michigan, United States, 49506 | |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| Spectrum Health Cancer Care - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| Holland Community Hospital | |
| Holland, Michigan, United States, 49423 | |
| Hackley Hospital | |
| Muskegon, Michigan, United States, 49443 | |
| Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| St. Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| Deaconess Billings Clinic Cancer Center | |
| Billings, Montana, United States, 59107 | |
| Deaconess Billings Clinic - Downtown | |
| Billings, Montana, United States, 59101 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| St. James Community Hospital | |
| Butte, Montana, United States, 59701 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Eastern Montana Cancer Center | |
| Miles City, Montana, United States, 59301 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59802 | |
| 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 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| Community Oncology Group - Independence | |
| Independence, Ohio, United States, 44131 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373 | |
| Cleveland Clinic - Wooster | |
| Wooster, Ohio, United States, 44691 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| United States, Oregon | |
| Legacy Mount Hood Medical Center | |
| Glesham, Oregon, United States, 97030 | |
| Providence Milwaukie Hospital | |
| Milwaukie, Oregon, United States, 97222 | |
| Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center | |
| Portland, Oregon, United States, 97210 | |
| Institute of Oncology at Vilnius University | |
| Portland, Oregon, United States, 97227 | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Providence Cancer Center at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| Legacy Meridian Park Hospital | |
| Tualatin, Oregon, United States, 97062 | |
| United States, Virginia | |
| Danville Regional Medical Center | |
| Danville, Virginia, United States, 24541 | |
| United States, Washington | |
| Auburn Regional Center for Cancer Care | |
| Auburn, Washington, United States, 98002 | |
| St. Joseph Hospital Community Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| Olympic Hematology and Oncology | |
| Bremerton, Washington, United States, 98310 | |
| Regional Cancer Center at Providence Hospital | |
| Centralia, Washington, United States, 98531 | |
| St. Francis Hospital | |
| Federal Way, Washington, United States, 98003 | |
| Skagit Valley Hospital Cancer Care Center | |
| Mt. Vernon, Washington, United States, 98273 | |
| Capital Medical Center | |
| Olympia, Washington, United States, 98507 | |
| Providence St. Peter Hospital Regional Cancer Center | |
| Olympia, Washington, United States, 95806 | |
| Good Samaritan Cancer Center | |
| Puyallup, Washington, United States, 98372 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98104 | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98114 | |
| Fred Hutchinson Cancer Research Center | |
| 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 | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| St. Clare Hospital | |
| Tacoma, Washington, United States, 98499 | |
| Allenmore Hospital | |
| Tacoma, Washington, United States, 98405 | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405 | |
| St. Joseph Medical Center at Franciscan Health System | |
| Tacoma, Washington, United States, 98405 | |
| Southwest Washington Medical Center Cancer Center | |
| Vancouver, Washington, United States, 98668 | |
| Central Washington Hospital | |
| Wenatchee, Washington, United States, 98801 | |
| 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 | |
Sponsors and Collaborators
Southwest Oncology Group
Investigators
| 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 Cancer Center |
More Information
Additional Information:
Publications:
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.
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00068367 History of Changes |
| Other Study ID Numbers: | CDR0000322023, S0330, U10CA032102 |
| Study First Received: | September 10, 2003 |
| Last Updated: | January 13, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Southwest Oncology Group:
|
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 |
Additional relevant MeSH terms:
|
Nerve Sheath Neoplasms Neurofibrosarcoma Neurilemmoma Sarcoma Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Peripheral Nervous System Neoplasms Nervous System Neoplasms Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Fibrosarcoma |
Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neurofibroma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroma Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013