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Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: July 8, 2004   Last Updated: September 11, 2008   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Functional and symptom status [ Designated as safety issue: No ]
  • Correlation of epidermal growth factor receptor (EGFR) expression levels and/or EGFR polymorphisms with progression-free and/or overall survival [ Designated as safety issue: No ]
  • Correlation of activated signal pathway molecules with response and/or survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response (confirmed, unconfirmed, complete, or partial response) rate [ Designated as safety issue: No ]

Study Start Date: September 2004
Detailed Description:

OBJECTIVES:

  • Determine survival of patients with advanced primary non-small cell lung cancer and a Zubrod performance status of 2 treated with erlotinib.
  • Determine the objective tumor response rates (confirmed, unconfirmed, complete, or partial) in patients treated with this drug.
  • Determine functional and symptom status in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.
  • Correlate, preliminarily, epidermal growth factor receptor (EGFR) expression levels and/or EGFR polymorphisms with progression-free and/or overall survival in patients treated with this drug.
  • Correlate, preliminarily, activated signal pathway molecules, including basal p27 expression levels, with response and/or survival in patients treated with this drug.

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
Criteria

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)

      • T4 lesion due to malignant pleural effusion only
      • Any N
      • M0
    • Stage IV disease

      • Any T
      • Any N
      • M1
    • Recurrent disease after prior surgery and/or radiotherapy
  • The following histologies are eligible:

    • Adenocarcinoma
    • Large cell carcinoma
    • Squamous cell carcinoma
    • Unspecified
  • Measurable disease by CT scan, MRI, x-ray, or physical or nuclear exam

    • Measurable disease must be outside prior irradiated fields OR a new lesion must be present
    • Measurable disease must be outside the area of prior surgical resection
  • No brain metastases

    • Negative CT scan or MRI if there are neurological abnormalities on physical exam or symptoms
  • Patients must be offered participation in protocol SWOG-S9925 (Lung Cancer Specimen Repository study)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ upper limit of normal (ULN) AND 1 of the following:

    • Alkaline phosphatase ≤ ULN AND SGOT OR SGPT ≤ 2 times ULN
    • Alkaline phosphatase ≤ 4 times ULN AND SGOT OR SGPT ≤ ULN

Renal

  • Creatinine ≤ 2 mg/dL

Cardiovascular

  • No significant history of cardiac disease
  • No uncontrolled high blood pressure
  • No unstable angina
  • No congestive heart failure
  • No cardiac ventricular arrhythmias requiring medication
  • No myocardial infarction within the past 6 months

Gastrointestinal

  • No GI tract disease resulting in an inability to take oral medication
  • No malabsorption syndrome
  • No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
  • No requirement for IV alimentation

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 in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for NSCLC
  • No concurrent biologic therapy

Chemotherapy

  • No prior systemic chemotherapy for NSCLC

Endocrine therapy

  • No prior hormonal therapy for NSCLC
  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy to measurable or non-measurable lesions

    • Concurrent palliative radiotherapy to small-field non-measurable sites of painful bony metastases allowed provided there are other sites of measurable disease outside of the radiotherapy treatment field

Surgery

  • See Disease Characteristics
  • At least 3 weeks since prior thoracic or other major surgeries and recovered
  • No prior surgical procedures affecting gastrointestinal (GI) absorption

Other

  • No prior epidermal growth factor receptor inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087412

  Hide Study Locations
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
Sponsors and Collaborators
Southwest Oncology Group
Investigators
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

Additional Information:
Publications:
Hesketh PJ, Chansky K, Wozniak AJ, Hirsch FR, Spreafico A, Moon J, Mack PC, Marchello BT, Franklin WA, Crowley JJ, Gandara DR. Southwest Oncology Group phase II trial (S0341) of erlotinib (OSI-774) in patients with advanced non-small cell lung cancer and a performance status of 2. J Thorac Oncol. 2008 Sep;3(9):1026-31.
Hesketh PJ, Chansky K, Wozniak AJ, et al.: Erlotinib as initial therapy in patients with advanced non-small cell lung cancer (NSCLC) and a performance status (PS) of 2: a SWOG phase II trial (S0341). [Abstract] J Clin Oncol 25 (Suppl 18): A-7536, 393s, 2007.

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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 30, 2009