S0720: Adjuvant Therapy Based on Gene Expression in Stage IA and IB Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
- Stage IA (longest tumor diameter 2-3 cm) or stage IB disease
- Must have undergone preoperative CT scan of the chest (including the entire liver and adrenals) with IV contrast AND a whole body PET scan or a combined PET/CT scan with no evidence of N1, N2, N3, or M1 disease within 42 days prior to surgery
A whole body PET scan or a combined PET/CT must be performed within 84 days
Any finding on PET scan that clinically suggests N1, N2, N3, or M1 disease must have been cleared by further evaluation, including, but not limited to, any of the following:
- Ultrasonography, X-ray radiology, magnetic resonance imaging, or nuclear medicine imaging
Completely resected (R0) disease by lobectomy, bilobectomy, or pneumonectomy performed by open thoracotomy or video-assisted thoracoscopic surgery within the past 35 days
- Completely excised primary lesion with negative gross and microscopic margins
- At least two mediastinal lymph node stations sampled
- Must have tumor tissue available from the surgical resection specimen AND agree to have treatment assignment determined by a gene expression analysis performed on that tissue
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 mg/dL
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 1.5 times ULN
- Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
No other prior malignancy except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I-II cancer from which the patient is currently in complete remission
- Any other cancer from which the patient has been disease-free for 5 years
- Willing to provide prior smoking history
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic chemotherapy or biologic therapy for lung cancer
- No prior thoracic radiation therapy (RT) (including RT to the chest wall)
No other concurrent investigational agents, chemotherapeutic agents, RT, or hormonal therapy
- Steroids administered for antiemesis, adrenal failure, or septic shock OR hormones administered for non-disease-related conditions (e.g., insulin for diabetes) allowed
Sites / Locations
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
- City of Hope Comprehensive Cancer Center
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP
- Valley Medical Oncology Consultants - Pleasanton
- Sutter Cancer Center at Roseville Medical Center
- Sutter Cancer Center
- University of California Davis Cancer Center
- Tahoe Forest Cancer Center
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Northeast Georgia Medical Center
- Tripler Army Medical Center
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Decatur Memorial Hospital Cancer Care Institute
- Sherman Hospital
- Regional Cancer Center at Memorial Medical Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Cancer Center of Kansas, PA - Wellington
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Cancer Center of Kansas, PA - Winfield
- Caritas St. Elizabeth's Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- Genesys Hurley Cancer Institute
- Lacks Cancer Center at Saint Mary's Health Care
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- Munson Medical Center
- St. John Macomb Hospital
- Metro Health Hospital
- Regional Cancer Center at Singing River Hospital
- Saint Francis Medical Center
- Saint Louis University Cancer Center
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Cancer Research for the Ozarks
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
- Rutherford Hospital
- Mary Rutan Hospital
- Adena Regional Medical Center
- Riverside Methodist Hospital Cancer Care
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Grady Memorial Hospital
- Blanchard Valley Medical Associates
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Knox Community Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Community Hospital of Springfield and Clark County
- UVMC Cancer Care Center at Upper Valley Medical Center
- Mount Carmel St. Ann's Cancer Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Providence Milwaukie Hospital
- Providence Cancer Center at Providence Portland Medical Center
- Adventist Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- AnMed Cancer Center
- Cancer Centers of the Carolinas - Easley
- Bon Secours St. Francis Health System
- Cancer Centers of the Carolinas - Faris Road
- Cancer Centers of the Carolinas - Grove Commons
- Cancer Centers of the Carolinas - Eastside
- CCOP - Greenville
- Self Regional Cancer Center at Self Regional Medical Center
- Cancer Centers of the Carolinas - Greer Medical Oncology
- Cancer Centers of the Carolinas - Greer Radiation Oncology
- Cancer Centers of the Carolinas - Seneca
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Cancer Centers of the Carolinas - Spartanburg
- M. D. Anderson Cancer Center at University of Texas
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Logan Regional Hospital
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- LDS Hospital
- Utah Cancer Specialists at UCS Cancer Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Columbia Basin Hematology
- Skagit Valley Hospital Cancer Care Center
- Harrison Poulsbo Hematology and Onocology
- Harborview Medical Center
- Minor and James Medical, PLLC
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- Evergreen Hematology and Oncology, PS
- Northwest Cancer Specialists at Vancouver Cancer Center
- Wenatchee Valley Medical Center
- Rocky Mountain Oncology
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
Arm II
Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.