RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of tumors. It is not yet known whether combination chemotherapy plus radiation therapy is more effective...
Date First Received: July 11, 2001
Last Updated: May 23, 2008
Verified by: National Cancer Institute (NCI), November 2004
Clinical Trial Phase: Phase 3 | Start Date: June 2001
Overall Status: Active, not recruiting
Brief Summary
Official Title: “A Phase III Trial Of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed By Maintenance Therapy With ZD 1839 Or Placebo In Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer”
Condition Keyword(s):
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of tumors. It is not yet known whether combination chemotherapy plus radiation therapy is more effective with or without gefitinib in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with or without gefitinib in treating unresectable stage III non-small cell lung cancer.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control
Detailed Clinical Trial Description
OBJECTIVES: - Compare cisplatin, etoposide, radiotherapy, and docetaxel with or without gefitinib, in terms of improving overall survival and progression-free survival, in patients with unresectable stage III non-small cell lung cancer. - Determine the toxicity profile of gefitinib in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to performance status (0 vs 1), stage (stage IIIA vs IIIB), measurability of lesion (measurable vs nonmeasurable), and histologic subtype (squamous vs nonsquamous).
Patients receive induction therapy comprising cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning within 24 hours after starting chemotherapy, patients receive concurrent induction radiotherapy 5 days a week for 5 weeks and then boost radiotherapy 5 days a week for 1.5 weeks.
Beginning approximately 4-8 weeks after completion of chemoradiotherapy, patients with stable or responding disease receive consolidation therapy comprising docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 3 courses.
Patients with stable or responding disease are randomized to one of two treatment arms for maintenance therapy. Patients begin maintenance therapy approximately 4-7 weeks after completion of consolidation therapy. - Arm I: Patients receive oral gefitinib daily. - Arm II: Patients receive oral placebo daily. In both arms, maintenance therapy continues for a maximum of 5 years in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 5 years and then annually for 5 years.
PROJECTED ACCRUAL: A total of 840 patients will be accrued for this study within 3.5 years.
Criteria for Participation in this Clinical Trial
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed newly diagnosed single, primary bronchogenic non-small cell lung cancer (NSCLC)
- Adenocarcinoma
- Non-lobar and non-diffuse bronchoalveolar cell carcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Unresectable stage IIIA disease
- Histologically or cytologically confirmed N2 status
- Multiple and/or bulky mediastinal lymph nodes on CT scan or x-ray
- Ineligible for induction chemotherapy or chemoradiotherapy followed by surgical resection
- Ineligible for or refused participation in SWOG-9336 OR
- Stage IIIB disease
- Pathologically or radiographically documented positive N3 nodes
- No positive supraclavicular or scalene lymph nodes with disease extending up into the cervical region OR
- Any documented T4 lesions invading the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina
- Mediastinal involvement without organ involvement allowed if soft tissue mass extends directly into the mediastinum
- Radiographic criteria for involvement of main pulmonary artery allowed if mediastinal soft tissue mass is present
- Single primary parenchymal lesion
- No other lesions on same or opposite sides of the lung
- No metastatic disease involving the contralateral chest, liver, or adrenals by CT scan of upper abdomen
- No malignant pleural or pericardial effusions
- Pleural effusions visible only on CT scan or too small to tap allowed
- Measurable or evaluable disease by CT scan, MRI, x-ray, or physical exam
- No brain 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:
- Not specified
Renal:
- Creatinine clearance at least 50 mL/min
Pulmonary:
- FEV_1 at least 2.0 L OR
- FEV_1 less than 2.0 L if predicted FEV_1 of the contralateral lung is greater than 800 mL by quantitative split function testing
Other:
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No other concurrent non-cancer-related illness that would preclude study therapy
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent colony-stimulating factors during induction therapy
Chemotherapy:
- See Disease Characteristics
- No prior chemotherapy for NSCLC
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy for NSCLC
Surgery:
- No prior surgical resection of NSCLC
- Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar diagnostic or staging surgery allowed
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Southwest Oncology Group
MBCCOP - Gulf Coast
Mobile Alabama 36607 United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson Arizona 85724 United States
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale Arizona 85259-5404 United States
CCOP - Western Regional, Arizona
Phoenix Arizona 85006-2726 United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix Arizona 85012 United States
Veterans Affairs Medical Center - Tucson
Tucson Arizona 85723 United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas 72205 United States
Veterans Affairs Medical Center - Little Rock
Little Rock Arkansas 72205 United States
CCOP - Bay Area Tumor Institute
Oakland California 94609-3305 United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa California 95403 United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange California 92868 United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles California 90095-1781 United States
University of California Davis Cancer Center
Sacramento California 95817 United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California 90033 United States
Veterans Affairs Medical Center - Loma Linda (Pettis)
Loma Linda California 92357 United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez California 94553 United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora Colorado 80010 United States
Veterans Affairs Medical Center - Denver
Denver Colorado 80220 United States
MBCCOP - Howard University Cancer Center
Washington District of Columbia 20060 United States
Mayo Clinic - Jacksonville
Jacksonville Florida 32224 United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa Florida 33612 United States
CCOP - Atlanta Regional
Atlanta Georgia 30342-1701 United States
MBCCOP - Hawaii
Honolulu Hawaii 96813 United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois 60153-5500 United States
CCOP - Carle Cancer Center
Urbana Illinois 61801 United States
CCOP - Central Illinois
Decatur Illinois 62526 United States
CCOP - Illinois Oncology Research Association
Peoria Illinois 61615-7828 United States
MBCCOP - University of Illinois at Chicago
Chicago Illinois 60612 United States
Swedish-American Regional Cancer Center
Rockford Illinois 61104-2315 United States
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago Illinois 60612 United States
Veterans Affairs Medical Center - Hines
Hines Illinois 60141 United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa 52403-1206 United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa 50309-1016 United States
Siouxland Hematology-Oncology Associates
Sioux City Iowa 51101-1733 United States
CCOP - Wichita
Wichita Kansas 67214-3882 United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Kansas 66160-7353 United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas 67218 United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington Kentucky 40536-0084 United States
Veterans Affairs Medical Center - Lexington
Lexington Kentucky 40502-2236 United States
CCOP - Ochsner
New Orleans Louisiana 70121 United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport Louisiana 71130-3932 United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana 70112 United States
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans Louisiana 70112 United States
Veterans Affairs Medical Center - New Orleans
New Orleans Louisiana 70112 United States
Veterans Affairs Medical Center - Shreveport
Shreveport Louisiana 71101-4295 United States
Cancer Research Center at Boston Medical Center
Boston Massachusetts 02118 United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan 48201-1379 United States
CCOP - Beaumont
Royal Oak Michigan 48073-6769 United States
CCOP - Grand Rapids
Grand Rapids Michigan 49503 United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan 48106 United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit Michigan 48202 United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield Michigan 48075 United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan 48109-0948 United States
Veterans Affairs Medical Center - Detroit
Detroit Michigan 48201-1932 United States
CCOP - Duluth
Duluth Minnesota 55805 United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota 55416 United States
Coborn Cancer Center
Saint Cloud Minnesota 56303 United States
Mayo Clinic Cancer Center
Rochester Minnesota 55905 United States
St. Mary's - Duluth Clinic Cancer Center
Duluth Minnesota 55805 United States
University of Mississippi Medical Center
Jackson Mississippi 39216-4505 United States
Veterans Affairs Medical Center - Jackson
Jackson Mississippi 39216 United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri 65807 United States
CCOP - Kansas City
Kansas City Missouri 64131 United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri 63141 United States
Saint Louis University Cancer Center
Saint Louis Missouri 63110 United States
CCOP - Montana Cancer Consortium
Billings Montana 59101 United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska 68106 United States
MBCCOP - University of New Mexico HSC
Albuquerque New Mexico 87131 United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque New Mexico 87108-5138 United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York New York 10032 United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York 14642 United States
NYU Cancer Institute at New York University Medical Center
New York New York 10016 United States
CCOP - Southeast Cancer Control Consortium
Goldsboro North Carolina 27534-9479 United States
Altru Cancer Center
Grand Forks North Dakota 58201 United States
CCOP - Merit Care Hospital
Fargo North Dakota 58122 United States
Medcenter One Health System
Bismarck North Dakota 58501-5505 United States
CCOP - Columbus
Columbus Ohio 43206 United States
CCOP - Dayton
Dayton Ohio 45429 United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio 45267-0501 United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio 44195-9001 United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati Ohio 45220-2288 United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio 45428-1002 United States
CCOP - Oklahoma
Tulsa Oklahoma 74136 United States
Oklahoma University Medical Center
Oklahoma City Oklahoma 73104 United States
Cancer Institute at Oregon Health and Science University
Portland Oregon 97201-3098 United States
CCOP - Columbia River Oncology Program
Portland Oregon 97225 United States
Veterans Affairs Medical Center - Portland
Portland Oregon 97207 United States
Allegheny General Hospital
Pittsburgh Pennsylvania 15212-4772 United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania 17822-2001 United States
CCOP - Greenville
Greenville South Carolina 29615 United States
CCOP - Upstate Carolina
Spartanburg South Carolina 29303 United States
Hollings Cancer Center at Medical University of South Carolina
Charleston South Carolina 29425 United States
Veterans Affairs Medical Center - Charleston
Charleston South Carolina 29401-5799 United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota 57104 United States
Rapid City Regional Hospital
Rapid City South Dakota 57709 United States
University of Tennessee Cancer Institute at Methodist Central Hospital
Memphis Tennessee 38104 United States
Veterans Affairs Medical Center - Memphis
Memphis Tennessee 38104 United States
Brooke Army Medical Center
Fort Sam Houston Texas 78234-6200 United States
CCOP - Scott and White Hospital
Temple Texas 76508 United States
Harrington Cancer Center
Amarillo Texas 79106 United States
MD Anderson Cancer Center at University of Texas
Houston Texas 77030-4095 United States
Medical City Dallas Hospital
Dallas Texas 75230 United States
University of Texas Health Science Center at San Antonio
San Antonio Texas 78229-3900 United States
University of Texas Medical Branch
Galveston Texas 77555-0565 United States
Veterans Affairs Medical Center - Amarillo
Amarillo Texas 79106 United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio Texas 78229 United States
Veterans Affairs Medical Center - Temple
Temple Texas 76504 United States
Huntsman Cancer Institute at University of Utah
Salt Lake City Utah 84112-5550 United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City Utah 84148 United States
CCOP - Northwest
Tacoma Washington 98405-0986 United States
CCOP - Virginia Mason Research Center
Seattle Washington 98101 United States
Puget Sound Oncology Consortium
Seattle Washington 98109 United States
Veterans Affairs Medical Center - Seattle
Seattle Washington 98108 United States
Centre Hospitalier Regional de Rimouski
Quebec G1S 4L8 Canada
Cross Cancer Institute
Edmonton Alberta T6G 1Z2 Canada
Lethbridge Cancer Clinic
Lethbridge Alberta T1J 1W5 Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna British Columbia V1Y 5L3 Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver British Columbia V5Z 4E6 Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria British Columbia V8R 6V5 Canada
G. Steinhoff Clinical Research
Victoria British Columbia V8V 3N1 Canada
Lions Gate Hospital
North Vancouver British Columbia V7L 2P9 Canada
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
Nanaimo British Columbia V9S 2B7 Canada
Prostate Centre at Vancouver General Hospital
Vancouver British Columbia V5Z 3J5 Canada
Providence Health Care - Vancouver
Vancouver British Columbia V6Z 1Y6 Canada
CancerCare Manitoba
Winnipeg Manitoba R3E 0V9 Canada
Doctor Leon Richard Oncology Centre
Moncton New Brunswick E1C 8X3 Canada
Moncton Hospital
Moncton New Brunswick E1C 6ZB Canada
Saint John Regional Hospital
Saint John New Brunswick E2L 4L2 Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns Newfoundland and Labrador A1B 3V6 Canada
Cape Breton Cancer Centre
Sydney Nova Scotia B1P 1P3 Canada
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
Halifax Nova Scotia B3H 1V7 Canada
Algoma Regional Cancer Program at Sault Area Hospital
Sault Sainte Marie Ontario P6A 2C4 Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor Ontario N8W 2X3 Canada
Cancer Centre of Southeastern Ontario
Kingston Ontario K7L 5P9 Canada
Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa Ontario L1G 2B9 Canada
Grand River Regional Cancer Centre at Grand River Hospital
Kitchner Ontario N2G 1G3 Canada
Hamilton and District Urology Research Group
Hamilton Ontario L8N 1T8 Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines Ontario L2R 5K3 Canada
Humber River Regional Hospital - Weston
Weston Ontario M9N 1N8 Canada
London Regional Cancer Program at London Health Sciences Centre
London Ontario N6A 4L6 Canada
Male Health Centre - North York
Toronto Ontario M6A 3B5 Canada
Male Health Centre - Oakville
Oakville Ontario L6H 3PI Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton Ontario L8V 5C2 Canada
Markham Stouffville Hospital
Markham Ontario L6B IAI Canada
Mount Sinai Hospital - Toronto
Toronto Ontario M5G 1X5 Canada
North York General Hospital, Ontario
North York Ontario M2K 1E1 Canada
Northeastern Ontario Regional Cancer Centre
Sudbury Ontario P3E 5J1 Canada
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
Ottawa Ontario K1H 8L6 Canada
Peterborough Oncology Clinic
Peterborough Ontario K9H 7B6 Canada
Princess Margaret Hospital
Toronto Ontario M5G 2M9 Canada
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay Ontario P7B 6V4 Canada
Royal Victoria Hospital of Barrie
Barrie Ontario L4M 6M2 Canada
Scarborough Hospital - General Site
Scarborough Ontario M1P 2V5 Canada
Southlake Regional Health Centre
Newmarket Ontario L3Y 2P9 Canada
St. Joseph's Health Centre - Toronto
Toronto Ontario M6R 1B5 Canada
St. Michael's Hospital - Toronto
Toronto Ontario M5B 1W8 Canada
Sunnybrook and Women's College Health Sciences Centre
North York Ontario M4N 3M5 Canada
Toronto East General Hospital
Toronto Ontario M4C 3E7 Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto Ontario M4N 3M5 Canada
Trillium Health Centre - Mississauga
Mississauga Ontario L5B 1B8 Canada
William Osler Health Centre
Brampton Ontario L6W 2Z8 Canada
Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
Charlottetown Prince Edward Island C1A 8T5 Canada
Centre Hospitalier de l'Universite de Montreal
Montreal Quebec (P.Q.) H2X 3J4 Canada
Centre Hospitalier Regional de Lanaudiere
Joliette Quebec J6E 6J2 Canada
Centre Hospitalier Universitaire de Quebec
Quebec City Quebec G1R 2J6 Canada
CHUS-Hopital Fleurimont
Sherbrooke Quebec J1H 5N4 Canada
Complexe Hospitalier de la Sagamie
Chicoutimi Quebec G7H 5H6 Canada
Hopital Charles Lemoyne
Greenfield Park Quebec J4V 2H1 Canada
Hopital Du Sacre-Coeur de Montreal
Montreal Quebec H4J 1C5 Canada
Hopital du Saint-Sacrement, Quebec
Quebec City Quebec G1S 4L8 Canada
Hopital Sainte Justine
Montreal Quebec H3T 1C5 Canada
Hotel Dieu de Montreal
Montreal Quebec H2W 1T8 Canada
Hotel-Dieu de Levis
Levis Quebec G6V 3Z1 Canada
L'Hopital Laval
Ste-Foy Quebec G1V 4G5 Canada
Maisonneuve-Rosemont Hospital
Montreal Quebec H1T 2M4 Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan S7N 4H4 Canada
Overall Clinical Trial Officials and Contacts
Karen Kelly, MD Study Chair University of Colorado at Denver and Health Sciences Center
Related Publications
Citations Reporting Results
Kelly K, Chansky K, Gaspar LE, Albain KS, Jett J, Ung YC, Lau DH, Crowley JJ, Gandara DR. Phase III Trial of Maintenance Gefitinib or Placebo After Concurrent Chemoradiotherapy and Docetaxel Consolidation in Inoperable Stage III Non-Small-Cell Lung Cancer: SWOG S0023. J Clin Oncol. 2008 Mar 31; [Epub ahead of print]
Kelly K, Chansky K, Gaspar LE, et al.: Updated analysis of SWOG 0023: a randomized phase III trial of gefitinib versus placebo maintenance after definitive chemoradiation followed by docetaxel in patients with locally advanced stage III non-small cell lung cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-7513, 388s, 2007.
Gaspar LE, McCoy J, Kelly K, et al.: Analysis of V20 and radiation pneumonitis on SWOG0023: a phase III trial of concurrent chemoradiation and docetaxel consolidation in stage III non-small cell lung cancer. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-108, S61-2, 2006.
Kelly K, Gaspar LE, Chansky K, et al.: Low incidence of pneumonitis on SWOG 0023: a preliminary analysis of an ongoing phase III trial of concurrent chemoradiotherapy followed by consolidation docetaxel and Iressa/placebo maintenance in patients with inoperable stage III non-small cell lung cancer. [Abstract] J Clin Oncol 23 (Suppl 16): A-7058, 634s, 2005.
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00020709
Study ID Number: CDR0000068706
ClinicalTrials.gov Identifier: NCT00020709
Health Authority: United States: Federal Government
Clinical trial summary from the National Cancer Institute's PDQ® database
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
