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Clinical Trials >> A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma
Mesothelioma Related Clinical Trials:
A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma
Status: Completed
Sponsors and Collaborators: Southwest Oncology Group, National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00039182
Condition: Malignant Mesothelioma
Intervention: Drug: erlotinib hydrochloride; Procedure: protein tyrosine kinase inhibitor therapy
Purpose:
RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung.
| Study Type: Â | Interventional |
| Study Design: Â | Treatment |
| Official Title: Â | A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma |
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: Â | May 2002 |
Detailed Description:
OBJECTIVES:
- Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib.
- Determine the response rate in patients with measurable disease treated with this drug.
- Determine the frequency and severity of toxic effects of this drug in these patients.
- Measure epidermal growth factor receptor (EGFR) expression, EGFR gene amplification, and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug.
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 are followed every 6 months for 2 years and then annually for 1 year.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14-18 months.
Eligibility:
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed malignant pleural mesothelioma
- Epithelial
- Sarcomatous
- Biphasic
- Measurable or nonmeasurable disease
- Not amenable to extrapleural pneumonectomy
- No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver involvement of tumor)
Renal:
- Creatinine no greater than 2 times ULN
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
- Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube
Ophthalmic:
-
No known history of the following:
- Dry eye syndrome
- Sjogren's syndrome
- Keratoconjunctivitis sicca
- Exposure keratopathy
- Fuch's dystrophy
- Other active disorders of the cornea
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No HIV-positive patients receiving combination antiretroviral therapy
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy for this tumor
Chemotherapy:
- No prior chemotherapy for this tumor
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior major surgery (e.g., thoracotomy or laparotomy), excluding minor surgeries (e.g., mediastinoscopy, thoracoscopy, or minor biopsies)
- Recovered from prior surgery
- No prior surgical procedures affecting absorption
Other:
- No prior investigational anticancer agents for this tumor
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039182Locations
| United States, Alabama | |||||
| MBCCOP - Gulf Coast   | |||||
| Â Â Â Mobile, Alabama, United States, 36688 | |||||
| University of Alabama at Birmingham Comprehensive Cancer Center   | |||||
| Â Â Â Birmingham, Alabama, United States, 35294-3300 | |||||
| United States, Arizona | |||||
| Arizona Cancer Center   | |||||
| Â Â Â Tucson, Arizona, United States, 85724 | |||||
| Veterans Affairs Medical Center - Tucson   | |||||
| Â Â Â Tucson, Arizona, United States, 85723 | |||||
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) Â Â | |||||
| Â Â Â Phoenix, Arizona, United States, 85012 | |||||
| CCOP - Greater Phoenix   | |||||
| Â Â Â Phoenix, Arizona, United States, 85006-2726 | |||||
| United States, Arkansas | |||||
| University of Arkansas for Medical Sciences   | |||||
| Â Â Â Little Rock, Arkansas, United States, 72205 | |||||
| Veterans Affairs Medical Center - Little Rock (McClellan) Â Â | |||||
| Â Â Â Little Rock, Arkansas, United States, 72205 | |||||
| United States, California | |||||
| CCOP - Bay Area Tumor Institute   | |||||
| Â Â Â Oakland, California, United States, 94609-3305 | |||||
| CCOP - Santa Rosa Memorial Hospital   | |||||
| Â Â Â Santa Rosa, California, United States, 95403 | |||||
| Chao Family Comprehensive Cancer Center   | |||||
| Â Â Â Orange, California, United States, 92868 | |||||
| City of Hope Comprehensive Cancer Center   | |||||
| Â Â Â Duarte, California, United States, 91010 | |||||
| David Grant Medical Center   | |||||
| Â Â Â Travis Air Force Base, California, United States, 94535 | |||||
| Jonsson Comprehensive Cancer Center, UCLA Â Â | |||||
| Â Â Â Los Angeles, California, United States, 90095-1781 | |||||
| University of California Davis Medical Center   | |||||
| Â Â Â Sacramento, California, United States, 95817 | |||||
| Veterans Affairs Medical Center - West Los Angeles   | |||||
| Â Â Â Los Angeles, California, United States, 90073 | |||||
| Veterans Affairs Outpatient Clinic - Martinez   | |||||
| Â Â Â Martinez, California, United States, 94553 | |||||
| United States, Colorado | |||||
| University of Colorado Cancer Center   | |||||
| Â Â Â Denver, Colorado, United States, 80010 | |||||
| Veterans Affairs Medical Center - Denver   | |||||
| Â Â Â Denver, Colorado, United States, 80220 | |||||
| United States, District of Columbia | |||||
| MBCCOP - Howard University Cancer Center   | |||||
| Â Â Â Washington, District of Columbia, United States, 20060 | |||||
| United States, Georgia | |||||
| CCOP - Atlanta Regional   | |||||
| Â Â Â Atlanta, Georgia, United States, 30342-1701 | |||||
| Dwight David Eisenhower Army Medical Center   | |||||
| Â Â Â Fort Gordon, Georgia, United States, 30905-5650 | |||||
| United States, Hawaii | |||||
| Cancer Research Center of Hawaii   | |||||
| Â Â Â Honolulu, Hawaii, United States, 96813-2424 | |||||
| Tripler Army Medical Center   | |||||
| Â Â Â Honolulu, Hawaii, United States, 96859-5000 | |||||
| United States, Illinois | |||||
| CCOP - Central Illinois   | |||||
| Â Â Â Decatur, Illinois, United States, 62526 | |||||
| Loyola University Medical Center   | |||||
| Â Â Â Maywood, Illinois, United States, 60153-5500 | |||||
| MBCCOP - University of Illinois at Chicago   | |||||
| Â Â Â Chicago, Illinois, United States, 60612-7323 | |||||
| Veterans Affairs Medical Center - Chicago (Westside Hospital) Â Â | |||||
| Â Â Â Chicago, Illinois, United States, 60612 | |||||
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Â Â | |||||
| Â Â Â Hines, Illinois, United States, 60141 | |||||
| United States, Kansas | |||||
| CCOP - Wichita   | |||||
| Â Â Â Wichita, Kansas, United States, 67214-3882 | |||||
| Veterans Affairs Medical Center - Wichita   | |||||
| Â Â Â Wichita, Kansas, United States, 67218 | |||||
| United States, Kentucky | |||||
| Albert B. Chandler Medical Center, University of Kentucky   | |||||
| Â Â Â Lexington, Kentucky, United States, 40536-0084 | |||||
| Veterans Affairs Medical Center - Lexington   | |||||
| Â Â Â Lexington, Kentucky, United States, 40502-2236 | |||||
| United States, Louisiana | |||||
| Louisiana State University Health Sciences Center - Shreveport   | |||||
| Â Â Â Shreveport, Louisiana, United States, 71130-3932 | |||||
| MBCCOP - LSU Medical Center   | |||||
| Â Â Â New Orleans, Louisiana, United States, 70112 | |||||
| Tulane University School of Medicine   | |||||
| Â Â Â New Orleans, Louisiana, United States, 70112 | |||||
| Veterans Affairs Medical Center - New Orleans   | |||||
| Â Â Â New Orleans, Louisiana, United States, 70112 | |||||
| Veterans Affairs Medical Center - Shreveport   | |||||
| Â Â Â Shreveport, Louisiana, United States, 71130 | |||||
| United States, Massachusetts | |||||
| Boston Medical Center   | |||||
| Â Â Â Boston, Massachusetts, United States, 02118 | |||||
| Veterans Affairs Medical Center - Boston (Jamaica Plain) Â Â | |||||
| Â Â Â Jamaica Plain, Massachusetts, United States, 02130 | |||||
| United States, Michigan | |||||
| Barbara Ann Karmanos Cancer Institute   | |||||
| Â Â Â Detroit, Michigan, United States, 48201-1379 | |||||
| CCOP - Ann Arbor Regional   | |||||
| Â Â Â Ann Arbor, Michigan, United States, 48106 | |||||
| CCOP - Beaumont   | |||||
| Â Â Â Royal Oak, Michigan, United States, 48073-6769 | |||||
| CCOP - Grand Rapids   | |||||
| Â Â Â Grand Rapids, Michigan, United States, 49503 | |||||
| Henry Ford Hospital   | |||||
| Â Â Â Detroit, Michigan, United States, 48202 | |||||
| Providence Hospital - Southfield   | |||||
| Â Â Â Southfield, Michigan, United States, 48075-9975 | |||||
| University of Michigan Comprehensive Cancer Center   | |||||
| Â Â Â Ann Arbor, Michigan, United States, 48109-0912 | |||||
| Veterans Affairs Medical Center - Ann Arbor   | |||||
| Â Â Â Ann Arbor, Michigan, United States, 48105 | |||||
| Veterans Affairs Medical Center - Detroit   | |||||
| Â Â Â Detroit, Michigan, United States, 48201-1932 | |||||
| United States, Minnesota | |||||
| CCOP - Duluth   | |||||
| Â Â Â Duluth, Minnesota, United States, 55805 | |||||
| United States, Mississippi | |||||
| Keesler Medical Center - Keesler AFB Â Â | |||||
| Â Â Â Keesler AFB, Mississippi, United States, 39534-2576 | |||||
| University of Mississippi Medical Center   | |||||
| Â Â Â Jackson, Mississippi, United States, 39216-4505 | |||||
| Veterans Affairs Medical Center - Biloxi   | |||||
| Â Â Â Biloxi, Mississippi, United States, 39531-2410 | |||||
| Veterans Affairs Medical Center - Jackson   | |||||
| Â Â Â Jackson, Mississippi, United States, 39216 | |||||
| United States, Missouri | |||||
| CCOP - St. Louis-Cape Girardeau   | |||||
| Â Â Â Saint Louis, Missouri, United States, 63141 | |||||
| CCOP - Kansas City   | |||||
| Â Â Â Kansas City, Missouri, United States, 64131 | |||||
| CCOP - Cancer Research for the Ozarks   | |||||
| Â Â Â Springfield, Missouri, United States, 65807 | |||||
| St. Louis University Health Sciences Center   | |||||
| Â Â Â Saint Louis, Missouri, United States, 63110 | |||||
| Veterans Affairs Medical Center - Kansas City   | |||||
| Â Â Â Kansas City, Missouri, United States, 64128 | |||||
| United States, Montana | |||||
| CCOP - Montana Cancer Consortium   | |||||
| Â Â Â Billings, Montana, United States, 59101 | |||||
| United States, New Mexico | |||||
| MBCCOP - University of New Mexico HSC Â Â | |||||
| Â Â Â Albuquerque, New Mexico, United States, 87131 | |||||
| Veterans Affairs Medical Center - Albuquerque   | |||||
| Â Â Â Albuquerque, New Mexico, United States, 87108-5138 | |||||
| United States, New York | |||||
| Herbert Irving Comprehensive Cancer Center   | |||||
| Â Â Â New York, New York, United States, 10032 | |||||
| University of Rochester Medical Center   | |||||
| Â Â Â Rochester, New York, United States, 14642 | |||||
| Veterans Affairs Medical Center - Albany   | |||||
| Â Â Â Albany, New York, United States, 12208 | |||||
| Western New York Urology Associates   | |||||
| Â Â Â Buffalo, New York, United States, 14220 | |||||
| United States, North Carolina | |||||
| CCOP - Southeast Cancer Control Consortium   | |||||
| Â Â Â Winston-Salem, North Carolina, United States, 27104-4241 | |||||
| United States, Ohio | |||||
| CCOP - Columbus   | |||||
| Â Â Â Columbus, Ohio, United States, 43206 | |||||
| Barrett Cancer Center   | |||||
| Â Â Â Cincinnati, Ohio, United States, 45267-0501 | |||||
| Arthur G. James Cancer Hospital - Ohio State University   | |||||
| Â Â Â Columbus, Ohio, United States, 43210-1240 | |||||
| CCOP - Dayton   | |||||
| Â Â Â Kettering, Ohio, United States, 45429 | |||||
| Cleveland Clinic Taussig Cancer Center   | |||||
| Â Â Â Cleveland, Ohio, United States, 44195-9001 | |||||
| Veterans Affairs Medical Center - Cincinnati   | |||||
| Â Â Â Cincinnati, Ohio, United States, 45220-2288 | |||||
| Veterans Affairs Medical Center - Dayton   | |||||
| Â Â Â Dayton, Ohio, United States, 45428 | |||||
| United States, Oklahoma | |||||
| Oklahoma Medical Research Foundation   | |||||
| Â Â Â Oklahoma City, Oklahoma, United States, 73104 | |||||
| Veterans Affairs Medical Center - Oklahoma City   | |||||
| Â Â Â Oklahoma City, Oklahoma, United States, 73104 | |||||
| United States, Oregon | |||||
| CCOP - Columbia River Program   | |||||
| Â Â Â Portland, Oregon, United States, 97225 | |||||
| Oregon Cancer Institute   | |||||
| Â Â Â Portland, Oregon, United States, 97239 | |||||
| Veterans Affairs Medical Center - Portland   | |||||
| Â Â Â Portland, Oregon, United States, 97207 | |||||
| United States, South Carolina | |||||
| CCOP - Greenville   | |||||
| Â Â Â Greenville, South Carolina, United States, 29615 | |||||
| Veterans Affairs Medical Center - Charleston   | |||||
| Â Â Â Charleston, South Carolina, United States, 29401-5799 | |||||
| Medical University of South Carolina   | |||||
| Â Â Â Charleston, South Carolina, United States, 29425-0721 | |||||
| CCOP - Upstate Carolina   | |||||
| Â Â Â Spartanburg, South Carolina, United States, 29303 | |||||
| United States, Texas | |||||
| University of Texas Health Science Center at San Antonio   | |||||
| Â Â Â San Antonio, Texas, United States, 78284-7845 | |||||
| Brooke Army Medical Center   | |||||
| Â Â Â Fort Sam Houston, Texas, United States, 78234-6200 | |||||
| CCOP - Scott and White Hospital   | |||||
| Â Â Â Temple, Texas, United States, 76508 | |||||
| Texas Tech University Health Science Center   | |||||
| Â Â Â Lubbock, Texas, United States, 79415 | |||||
| University of Texas - MD Anderson Cancer Center   | |||||
| Â Â Â Houston, Texas, United States, 77030-4095 | |||||
| Baylor College of Medicine   | |||||
| Â Â Â Houston, Texas, United States, 77030 | |||||
| University of Texas Medical Branch   | |||||
| Â Â Â Galveston, Texas, United States, 77555-0565 | |||||
| Veterans Affairs Medical Center - Houston   | |||||
| Â Â Â Houston, Texas, United States, 77030 | |||||
| Veterans Affairs Medical Center - San Antonio (Murphy) Â Â | |||||
| Â Â Â San Antonio, Texas, United States, 78284 | |||||
| Veterans Affairs Medical Center - Temple   | |||||
| Â Â Â Temple, Texas, United States, 76504 | |||||
| United States, Utah | |||||
| Huntsman Cancer Institute   | |||||
| Â Â Â Salt Lake City, Utah, United States, 84112-5550 | |||||
| Veterans Affairs Medical Center - Salt Lake City   | |||||
| Â Â Â Salt Lake City, Utah, United States, 84148 | |||||
| United States, Virginia | |||||
| Eastern Virginia Medical School   | |||||
| Â Â Â Norfolk, Virginia, United States, 23510-1115 | |||||
| United States, Washington | |||||
| CCOP - Northwest   | |||||
| Â Â Â Tacoma, Washington, United States, 98405-0986 | |||||
| CCOP - Virginia Mason Research Center   | |||||
| Â Â Â Seattle, Washington, United States, 98101 | |||||
| Madigan Army Medical Center   | |||||
| Â Â Â Tacoma, Washington, United States, 98431-5000 | |||||
| Swedish Cancer Institute   | |||||
| Â Â Â Seattle, Washington, United States, 98104 | |||||
| Veterans Affairs Medical Center - Seattle   | |||||
| Â Â Â Seattle, Washington, United States, 98108 | |||||
Sponsors and Collaborators
| Southwest Oncology Group |
| National Cancer Institute (NCI) |
Investigators
| Study Chair:   | Linda Garland, MD   | University of Arizona   |
Additional Information:
Publications of Results:| Garland LL, Rankin C, Gandara DR, Rivkin SE, Scott KM, Nagle RB, Klein-Szanto AJ, Testa JR, Altomare DA, Borden EC. Phase II study of erlotinib in patients with malignant pleural mesothelioma: a Southwest Oncology Group Study. J Clin Oncol. 2007 Jun 10;25(17):2406-13. Â |
| Garland L, Rankin C, Scott K, et al.: Molecular correlates of the EGFR signaling pathway in association with SWOG S0218: a phase II study of oral EGFR tyrosine kinase inhibitor OSI-774 (NSC-718781) in patients with malignant pleural mesothelioma (MPM). [Abstract] J Clin Oncol 22 (Suppl 14): A-3007, 196s, 2004. |
| Study ID Numbers: Â | CDR0000069360, SWOG-S0218 |
| First Received: Â | June 6, 2002 |
| Last Updated: Â | December 15, 2007 |
| ClinicalTrials.gov Identifier: Â | NCT00039182 |
| Health Authority: Â | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
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Study placed in the following topic categories:
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Additional relevant MeSH terms:
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