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Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed
This study is ongoing, but not recruiting participants.
First Received: November 12, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: NCIC Clinical Trials Group
Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Southwest Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049543
  Purpose

RATIONALE: Biological therapies such as gefitinib may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether gefitinib is effective in delaying the recurrence of non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in treating patients who have undergone surgery for stage IB, stage II, or stage IIIA non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: gefitinib
Procedure: adjuvant therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Official Title: A Phase III Prospective Randomized, Double-Blind, Placebo-Controlled Trial of the Epidermal Growth Factor Receptor Antagonist, ZD1839 (Iressa) in Completely Resected Primary Stage IB, II and IIIA Non-Small Cell Lung Cancer

Resource links provided by NLM:


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

Study Start Date: September 2002
Detailed Description:

OBJECTIVES:

Primary

  • Compare the overall survival of patients with completely resected primary stage IB, II, or IIIA non-small cell lung cancer treated with gefitinib vs placebo.

Secondary

  • Compare the disease-free survival of patients treated with these regimens.
  • Determine the prognostic significance of epidermal growth factor receptor expression, phosphorylation, and mutations in the primary tumor in predicting relative impact of gefitinib on survival of these patients.
  • Establish a comprehensive tumor bank linked to a clinical database for further study of molecular markers in patients treated with these regimens.
  • Determine the toxicity of gefitinib in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (IB vs II vs IIIA), histological subtype (squamous cell vs others), postoperative radiotherapy (yes vs no), prior adjuvant platinum-based chemotherapy (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral gefitinib daily, unless otherwise directed by the investigator.
  • Arm II: Patients receive oral placebo daily, unless otherwise directed by the investigator.

Treatment in both arms continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, 3 months, and every 3 months for 30 months after randomization, then every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,242 patients (621 per treatment arm) will be accrued for this study within 3.5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary non-small cell lung cancer (NSCLC)

    • Bronchoalveolar carcinoma presenting as discrete solitary radiological mass or nodule allowed
    • Stage IB, II, or IIIA disease
    • Completely resected by lobectomy, sleeve resection, bilobectomy, or pneumonectomy within the past 16 weeks (26 weeks for patients who received adjuvant platinum-based chemotherapy)

      • Mediastinal lymph node resection or lymph node sampling attempted with no evidence of metastatic involvement
      • Patients without a complete mediastinal lymph node resection or lymph node sampling must have undergone biopsy of any mediastinal lymph node measuring 1.5 cm or more on pre-surgical CT/MRI scan or any area of increased uptake in the mediastinum on pre-surgical PET scan
  • No combination of small cell and non-small cell carcinoma or pulmonary carcinoid tumor
  • No more than 1 discrete area of apparent primary cancer (even within the same lobe)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • No uncontrolled congestive heart failure
  • No angina
  • No arrhythmias

Other

  • No active uncontrolled infection
  • No clinically significant or untreated ophthalmologic conditions (e.g., Sjögren's syndrome)
  • No clinically significant or untreated gastrointestinal conditions (e.g., Crohn's disease or ulcerative colitis)
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other concurrent malignancy
  • No prior allergic reaction to compounds of similar chemical or biological composition to gefitinib
  • No history of psychiatric or neurologic disorder that would preclude study compliance
  • No active pathological condition that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior neoadjuvant immunotherapy for NSCLC

Chemotherapy

  • See Disease Characteristics
  • Prior adjuvant platinum-based chemotherapy allowed
  • At least 3 weeks since prior adjuvant platinum-based chemotherapy for NSCLC and recovered
  • No prior non-platinum-based chemotherapy
  • No prior neoadjuvant chemotherapy for NSCLC

Endocrine therapy

  • Not specified

Radiotherapy

  • Prior preoperative limited-field, low-dose external beam radiotherapy (less than 1,000 cGy) or endobronchial brachytherapy allowed
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior full-dose preoperative radiotherapy with curative intent

Surgery

  • See Disease Characteristics
  • Recovered from prior oncologic or other major surgery

Other

  • Prior laser therapy for short-term control of hemoptysis or lobar obstruction allowed
  • No other concurrent anticancer therapy
  • No concurrent drugs that induce CYP3A4 enzymes (e.g., phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum [St. John's wort])
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049543

  Hide Study Locations
Locations
United States, Arizona
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
United States, Arkansas
Veterans Affairs Medical Center - Little Rock
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California Davis Cancer Center
Sacramento, California, United States, 95817-2280
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
United States, Colorado
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, District of Columbia
Howard University Cancer Center at Howard University Hospital
Washington, District of Columbia, United States, 20060
Providence Hospital
Washington, District of Columbia, United States, 20017
United States, Florida
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
La Grange Oncology Associates
La Grange, Illinois, United States, 60525
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States, 60141
United States, Iowa
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
United States, Kansas
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Kentucky
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40502-2236
United States, Louisiana
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71101-4295
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
United States, Mississippi
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
United States, Nebraska
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68128-4157
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States, 14621
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, Ohio
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428-1002
United States, Oregon
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg, Pennsylvania, United States, 17110
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States, 29401-5799
United States, Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital
Memphis, Tennessee, United States, 38104
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, United States, 79106
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78229
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
United States, Utah
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Washington
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Algoma Regional Cancer Program at Sault Area Hospital
Sault Sainte Marie, Ontario, Canada, P6A 2C4
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Cancer Centre of Southeastern Ontario
Kingston, Ontario, Canada, K7L 5P9
Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada, L2R 5K3
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
St. Joseph's Health Centre - Toronto
Toronto, Ontario, Canada, M6R 1B5
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Trillium Health Centre - Mississauga
Mississauga, Ontario, Canada, L5B 1B8
Canada, Prince Edward Island
Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Hopital Notre- Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Hotel-Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Peru
Instituto de Enfermedades Neoplasicas
Lima, Peru, 34
Puerto Rico
San Juan City Hospital
San Juan, Puerto Rico, 00936-7344
Sponsors and Collaborators
NCIC Clinical Trials Group
Eastern Cooperative Oncology Group
Southwest Oncology Group
Investigators
Study Chair: Glenwood D. Goss, MD, BCh, FCP, FRCPC Ottawa Hospital Regional Cancer Centre - General Campus
Study Chair: Gregory A. Masters, MD Robert H. Lurie Cancer Center
Study Chair: Peter F. Roberts, MD University of California, Davis
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000258118, CAN-NCIC-BR19, ECOG-CAN-NCIC-BR19, SWOG-CAN-NCIC-BR19
Study First Received: November 12, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00049543     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
large cell lung cancer
squamous cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Gefitinib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009