Not Signed In -
Sarcoma, Uterine |
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Clinical Trial: Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
This study is currently recruiting patients.
Purpose
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have unresectable or metastatic malignant peripheral nerve sheath tumor.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| 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 | Drug: erlotinib Procedure: enzyme inhibitor therapy Procedure: protein tyrosine kinase inhibitor therapy | Phase II |
MedlinePlus related topics: Soft Tissue Sarcoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Erlotinib in Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
Further Study Details:
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 above, Genders Eligible for Study: Both
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 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
Location and Contact Information
Alabama
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
Paul O. Schwarzenberger, MD 251-544-1013
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
Thomas P. Miller, MD 520-626-2667
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
David Kyle King, MD, FACP 602-239-2413 david.king@baannerhealth.com
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting
Thomas Dale Kummet, MD 602-277-5551
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting
Harinder S. Garewal, MD 520-629-4686
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
Laura Fulper Hutchins, MD 501-686-8511 LFHutchins@uams.edu
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, 72205, United States; Recruiting
Bart Barlogie, MD 501-526-2873
California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting
Joseph Szumowski, MD 510-465-8570
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting
Ian C. Anderson, MD 707-521-3830
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
Randall F. Holcombe, MD 714-456-5153 rholcomb@uci.edu
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Clinical Trials Office - New Patient Services 800-826-4673 becomingapatient@coh.org
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
John L. Barstis, MD 310-825-5268
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting
Heinz-Josef Lenz, MD 323-865-3955 lenz@usc.edu
Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda, California, 92357, United States; Recruiting
Mark E. Reeves, MD, PhD 909-583-6064
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting
David R. Gandara, MD 925-372-2064
Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting
Anthony D. Elias, MD 720-848-1622 Anthony.Elias@uchsc.edu
Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting
Madeleine A. Kane, MD, PhD 303-399-8020 ext. 3129 madeleine.kane@med.va.gov
District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Lucile L. Adams-Campbell, PhD 202-806-7697
Florida
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Raoul R. Salup, MD 813-972-7579 raoul.salup@med.va.gov
Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting
Thomas E. Seay, MD, PhD 404-851-2340
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Brian F. Issell, MD 808-586-3015 brian@crch.hawaii.edu
Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting
Patrick J. Stiff, MD 708-327-3148
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
James L. Wade, MD 217-876-6617 jlwade3@sbcglobal.net
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-569-6129
Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141, United States; Recruiting
Nirmala Bhoopalam, MD 708-202-2782
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-268-5784
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7353, United States; Recruiting
Sarah A. Taylor, MD 913-588-6029 sataylor@kumc.edu
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-685-2221
Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Michael A. Doukas, MD 859-257-3379
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting
Michael A. Doukas, MD 859-281-4956
Louisiana
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting
Glenn M. Mills, MD 318-675-5970 gmills@lsuhsc.edu
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Jill Gilbert, MD 504-568-5613 jgilbe@lsuhsc.edu
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Alan M. Miller, MD, PhD 504-587-7566 amiller@tulane.edu
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting
German S. Beltran, MD 504-588-5482
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71101-4295, United States; Recruiting
Glenn M. Mills, MD 318-221-8411
Massachusetts
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Douglas V. Faller, MD, PhD 617-638-4173
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
Lawrence E. Flaherty, MD 313-745-9155 flaherty@karmanos.org
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
Jeanne Archer, PhD, APN 248-551-8299 carcher@beaumon.edu
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
Kathleen Jo Yost, MD 616-391-1230
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237 beekmanl@trinity-health.org
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Robert Anthony Chapman, MD 313-916-1332 rchapma1@hfhs.org
Providence Cancer Institute at Providence Hospital - Southfield, Southfield, Michigan, 48075, United States; Recruiting
Anibal Drelichman, MD, MPH, FACP 313-552-0620 adrelichman@yahoo.com
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0948, United States; Recruiting
Laurence H. Baker, DO, FACOI 734-936-3983 bakerl@umich.edu
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Lawrence E. Flaherty, MD 313-576-1000
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
James Tate Thigpen, MD 601-984-5590 jthigpen@medicine.umsmed.edu
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting
James Tate Thigpen, MD 601-362-4471
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
John Wendall Goodwin, MD 417-269-4520 jwg684@sprg.mercy.net
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting
Bethany G. Sleckman, MD 314-569-6573
Saint Louis University Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting
Paul J. Petruska, MD 314-268-5451 petruspj@slu.edu
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting
Patrick W. Cobb, MD 406-259-2245
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Cheryl L. Willman, MD 505-272-5837
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States; Recruiting
Cheryl L. Willman, MD 505-265-1711
New York
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
Daniel P. Petrylak, MD 212-305-1731 dpp5@columbia.edu
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Richard I. Fisher, MD 585-275-0842 richard_fisher@urmc.rochester.edu
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Amy D. Tiersten, MD 212-652-1916
North Carolina
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
James N. Atkins, MD 336-777-3088
Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
J. Philip Kuebler, MD, PhD 614-488-2118
CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting
Howard M. Gross, MD 937-832-1093
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0501, United States; Recruiting
Abdul-Rahman Jazieh, MD, MPH 513-584-3830
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-9001, United States; Recruiting
George Thomas Budd, MD 216-444-6480
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States; Recruiting
Albert F. Muhleman, MD 513-475-6537 albert.muhleman@med.va.gov
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428-1002, United States; Recruiting
Howard M. Gross, MD 937-268-6511
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Daniel J. Culkin, MD, FACS 405-271-6900 daniel-culkin@ouhsc.edu
Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States; Recruiting
Craig R. Nichols, MD 503-494-6346
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Keith S. Lanier, MD 503-216-6260
Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States; Recruiting
Christopher W. Ryan, MD 503-220-8262
South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States; Recruiting
Jeffrey Kent Giguere, MD 864-241-6251
CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting
James Dewitt Bearden, MD 864-560-7050
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Carolyn E. Reed, MD 843-792-9321 reedce@musc.edu
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting
Carolyn E. Reed, MD 843-789-7804
Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Mohammad Jahanzeb, MD 901-722-0532
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, 38104, United States; Recruiting
Harvey B. Niell, MD 901-523-8990 ext. 5533
Texas
Brooke Army Medical Center, Fort Sam Houston, Texas, 78234-6200, United States; Recruiting
Mitchell A. Garrison, MD 210-916-3281 mitchell.garrison@cen.amedd.army.mil
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting
James E. Clarkson, MD 806-359-4673 ext. 228 jclarkson@harringtoncc.org
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4095, United States; Recruiting
Scott Michael Lippman, MD, FACP 713-745-3672
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229-3900, United States; Recruiting
Geoffrey R. Weiss, MD 210-567-4777 weiss@uthscsa.edu
University of Texas Medical Branch, Galveston, Texas, 77555-0565, United States; Recruiting
Robert P. Whitehead, MD 409-772-1164 rpwhiteh@utmb.edu
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting
Stephen E. Wright, MD 806-359-4673 ext. 230
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting
Geoffrey R. Weiss, MD 210-617-5186
Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States; Recruiting
Phalguni Mukhopadhyay, MD 254-778-4811 ext. 4809
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112-5550, United States; Recruiting
Wolfram Samlowski, MD 801-585-0255 wolfram.samlowski@hci.utah.edu
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States; Recruiting
Wolfram Samlowski, MD 801-582-1565 ext. 1272
Washington
CCOP - Northwest, Tacoma, Washington, 98405-0986, United States; Recruiting
Lauren Kenneth Colman, MD 253-403-5259 lauren.colman@multicare.org
CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States; Recruiting
Andrew David Jacobs, MD 206-341-0446
Puget Sound Oncology Consortium, Seattle, Washington, 98109, United States; Recruiting
Saul E. Rivkin, MD 206-386-2441
Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States; Recruiting
William H. Schubach, MD 206-764-2265
Study chairs or principal investigators
Karen Albritton, MD, Dana-Farber/Harvard Cancer Center
R. Lor Randall, MD, University of Utah
Scott M. Schuetze, MD, PhD, University of Michigan Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000322023; SWOG-S0330; NCT00068367
Record last reviewed: September 2004
Last Updated: March 28, 2005
Record first received: September 10, 2003
ClinicalTrials.gov Identifier: NCT00068367
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: September 2004
Last Updated: March 28, 2005
Record first received: September 10, 2003
ClinicalTrials.gov Identifier: NCT00068367
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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