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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00087412 |
Purpose
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: erlotinib hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Trial Of OSI-774 (NSC-718781) In Patients With Advanced Non-Small Cell Lung Cancer And A Performance Status Of 2 |
| Study Start Date: | September 2004 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria:
Selected stage IIIB disease (excluding Pancoast tumors)
Stage IV disease
The following histologies are eligible:
Measurable disease by CT scan, MRI, x-ray, or physical or nuclear exam
No brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin ≤ upper limit of normal (ULN) AND 1 of the following:
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent radiotherapy to measurable or non-measurable lesions
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Alaska | |
| Alaska Regional Hospital | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Sana Rosa, California, United States, 95405 | |
| Saint Rose Hospital | |
| Hayward, California, United States, 94545 | |
| Highland General Hospital at St. George's University School of Medicine | |
| Oakland, California, United States, 94602 | |
| J.C. Robinson, M.D. Regional Cancer Center | |
| San Pablo, California, United States, 94806 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010 | |
| Summit Medical Center | |
| Oakland, California, United States, 94609 | |
| University of California Davis Cancer Center | |
| Davis, California, United States, 95616 | |
| Valley Memorial Hospital | |
| Livermore, California, United States, 94550 | |
| United States, Colorado | |
| Exempla Lutheran Medical Center | |
| Wheat Ridge, Colorado, United States, 80033 | |
| St. Anthony North Hospital | |
| Westminster, Colorado, United States, 80030 | |
| Poudre Valley Hospital | |
| Fort Collins, Colorado, United States, 80524 | |
| St. Anthony Central Hospital | |
| Denver, Colorado, United States, 80204 | |
| Montrose Memorial Hospital Cancer Center | |
| Montrose, Colorado, United States, 81401 | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80217-3364 | |
| Veterans Affairs Medical Center - Denver | |
| Denver, Colorado, United States, 80220 | |
| United States, Georgia | |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403 | |
| Pearlman Comprehensive Cancer Center at South Georgia Medical Center | |
| Valdosta, Georgia, United States, 31603 | |
| United States, Illinois | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Saint Anthony's Hospital at Saint Anthony's Health Center | |
| Alton, Illinois, United States, 62002 | |
| United States, Indiana | |
| St. Francis Hospital and Health Centers | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Iowa | |
| Genesis Medical Center - West Campus | |
| Davenport, Iowa, United States, 52804 | |
| Genesis Regional Cancer Center at Genesis Medical Center | |
| Davenport, Iowa, United States, 52803 | |
| United States, Kansas | |
| Associates in Womens Health | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Cancer Center of Kansas - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| Cancer Center of Kansas, P.A. - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, P.A. - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Cancer Center of Kansas, P.A. | |
| Wichita, Kansas, United States, 67208 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, P.A. - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Pratt Cancer Center of Kansas | |
| Pratt, Kansas, United States, 67124 | |
| Salina Regional Health Center | |
| Salina, Kansas, United States, 67401 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| St. Francis Comprehensive Cancer Center | |
| Topeka, Kansas, United States, 66606 | |
| Stormont-Vail Cancer Center | |
| Topeka, Kansas, United States, 66604 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| James Graham Brown Cancer Center at University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
| Shreveport, Louisiana, United States, 71130 | |
| Louisiana State University Health Sciences Center - Monroe | |
| Monroe, Louisiana, United States, 71210 | |
| Veterans Affairs Medical Center - Shreveport | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Massachusetts | |
| Cancer Research Center at Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Caritas St. Elizabeth's Medical Center | |
| Boston, Massachusetts, United States, 02135-2997 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48202 | |
| Battle Creek Health System Cancer Care Center | |
| Battle Creek, Michigan, United States, 49017 | |
| Bay Regional Medical Center | |
| Bay City, Michigan, United States, 48708 | |
| Breslin Cancer Center at Ingham Regional Medical Center | |
| East Lansing, Michigan, United States, 48824-1313 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| Hackley Hospital | |
| Muskegon, Michigan, United States, 49443 | |
| Holland Community Hospital | |
| Holland, Michigan, United States, 49423 | |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| Mecosta County General Hospital | |
| Big Rapids, Michigan, United States, 49307 | |
| Mercy Hospital | |
| Port Huron, Michigan, United States, 48060 | |
| Metropolitan Hospital | |
| Grand Rapids, Michigan, United States, 49506 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | |
| Southfield, Michigan, United States, 48075 | |
| Spectrum Health Cancer Care - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| Spectrum Health Hospital - Blodgett Campus | |
| Grand Rapids, Michigan, United States, 49506 | |
| Ted B. Wahby Cancer Center at Mount Clemens General Hospital | |
| Mount Clemens, Michigan, United States, 48043 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Mississippi | |
| Keesler Medical Center - Keesler Air Force Base | |
| Kessler AFB, Mississippi, United States, 39534-2519 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65802 | |
| CCOP - St. Louis-Cape Girardeau | |
| St. Louis, Missouri, United States, 63141 | |
| David C. Pratt Cancer Center at St. John's Mercy | |
| St. Louis, Missouri, United States, 63141 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| Saint Louis University Cancer Center | |
| St Louis, Missouri, United States, 63110 | |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | |
| Gape Girardeau, Missouri, United States, 63701 | |
| St. Francis Medical Center | |
| Cape Girardeau, Missouri, United States, 63701 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| United States, Montana | |
| Big Sky Oncology | |
| Great Falls, Montana, United States, 59405 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| Sletten Regional Cancer Institute | |
| Great Falls, Montana, United States, 59405 | |
| United States, New York | |
| Adirondack Cancer Care | |
| Glens Falls, New York, United States, 12801 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Tucker Center for Cancer Care at Orange Regional Medical Center | |
| Middletown, New York, United States, 10940 | |
| United States, North Carolina | |
| Annie Penn Cancer Center | |
| Reidsville, North Carolina, United States, 27320 | |
| John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital | |
| Eden, North Carolina, United States, 27288 | |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | |
| Greensboro, North Carolina, United States, 27401 | |
| Pardee Memorial Hospital | |
| Hendersonville, North Carolina, United States, 28791 | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233 | |
| Randolph Hospital | |
| Asheboro, North Carolina, United States, 27203 | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| 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 | |
| Community Oncology Group - Independence | |
| Independence, Ohio, United States, 44131 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| United States Air Force Medical Center Wright-Patterson | |
| Wright-Patterson Afb, Ohio, United States, 45433-5529 | |
| 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, South Carolina | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29304 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| McLeod Regional Medical Center | |
| Florence, South Carolina, United States, 29506 | |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | |
| Anderson, South Carolina, United States, 29621 | |
| United States, Tennessee | |
| University of Tennessee Cancer Institute at Methodist Central Hospital | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Huntsman Cancer Institute at University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Virginia | |
| Danville Regional Medical Center | |
| Danville, Virginia, United States, 24541 | |
| United States, Washington | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| Central Washington Hospital | |
| Wenatchee, Washington, United States, 98801 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98104 | |
| Wenatchee Valley Clinic | |
| Wenatchee, Washington, United States, 98801 | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Olympic Hematology and Oncology | |
| Bremerton, Washington, United States, 98310 | |
| Skagit Valley Hospital Cancer Care Center | |
| Mt. Vernon, Washington, United States, 98273 | |
| St. Joseph Hospital Community Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| 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 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98104 | |
| Study Chair: | Paul J. Hesketh, MD | Caritas St. Elizabeth's Medical Center of Boston |
| Investigator: | Antoinette J. Wozniak, MD | Barbara Ann Karmanos Cancer Institute |
More Information
| Study ID Numbers: | CDR0000377245, SWOG-S0341 |
| Study First Received: | July 8, 2004 |
| Last Updated: | September 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00087412 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
adenocarcinoma of the lung large cell lung cancer squamous cell lung cancer |
|
Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |