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| 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 |
| Study Start Date: | September 2002 |
OBJECTIVES:
Primary
Secondary
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.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed primary non-small cell lung cancer (NSCLC)
Completely resected by lobectomy, sleeve resection, bilobectomy, or pneumonectomy within the past 16 weeks (26 weeks for patients who received adjuvant platinum-based chemotherapy)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study 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 | |
| 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
| 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 |
|
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 |
|
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 |