Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Inoperable stage IIB OR Unresectable stage IIIA or IIIB No evidence of hematogenous metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 2 AND more than 5% weight loss over the past 3 months OR Zubrod 0-1 AND less than 5% weight loss over the past 3 months and refuses chemotherapy or are medically unable to tolerate combined modality therapy Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin no greater than 2 times upper limit of normal International Normalized Ratio (INR) no greater than 3.0 if taking warfarin Renal Creatinine clearance at least 50 mL/min Other No active gastrointestinal ulcers or bleeding within the past 3 months No other malignancy within the past 3 years except nonmelanoma skin cancer No known hypersensitivity to celecoxib No prior allergic-type reactions to sulfonamides No prior asthma, urticaria, or allergic-type reactions to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior neoadjuvant chemotherapy No concurrent chemotherapy Endocrine therapy No concurrent corticosteroids Radiotherapy No prior thoracic radiotherapy Surgery No prior complete or subtotal tumor resection Other No concurrent NSAIDs, lithium, furosemide, or angiotensin-converting enzyme inhibitors Concurrent aspirin (325 mg/day) for cardioprotection allowed
Sites / Locations
- Memorial Hospital Cancer Center
- University of Florida Shands Cancer Center
- Baptist Cancer Institute - Jacksonville
- University of Miami Sylvester Comprehensive Cancer Center
- Regional Radiation Oncology Center at Rome
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
- Indiana University Cancer Center
- Wendt Regional Cancer Center at Finley Hospital
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- West Michigan Cancer Center
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- CCOP - Metro-Minnesota
- Park Nicollet Clinic
- CCOP - Kansas City
- St. John's Regional Health Center
- Monmouth Medical Center
- Fox Chase Virtua Health Cancer Program - Marlton
- Albuquerque Regional Medical Center at Lovelace Sandia Health System
- University of New Mexico Cancer Research and Treatment Center
- Trinity Cancer Care Center
- Akron City Hospital at Summa Health System
- Radiation Oncology Center
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
- Cancer Treatment Center
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Bryn Mawr Hospital
- Cancer Center at Paoli Memorial Hospital
- Fox Chase Cancer Center
- Mercy Hospital Cancer Center - Scranton
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- CCOP - Greenville
- CCOP - Upstate Carolina
- Utah Valley Regional Medical Center - Provo
- LDS Hospital
- Dixie Regional Medical Center
- St. Joseph Hospital Community Cancer Center
- North Star Lodge Cancer Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- Community Memorial Hospital
- Medical College of Wisconsin Cancer Center
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
- All Saints Cancer Center at All Saints Healthcare
- University of Wisconsin Cancer Center at Aspirus Wausau Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Phase I: Celecoxib 200mg BID + RT
Phase I: Celecoxib 400mg BID + RT
Phase II: Celecoxib 400mg BID + RT
COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression. Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.
COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression. Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.
COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression. Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.