Combination Chemotherapy Plus Radiation Therapy in Treating Patients With 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, 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 (NSCLC) Stage I, II, or III NSCLC that is unresectable due to tumor extent or other medical reasons Measurable disease Tumor must not exceed volume that would require radiation volumes greater than those allowed on this study No more than blunting of the costophrenic angle on chest x-ray due to pleural effusions No more than small effusions seen on chest CT scan only No supraclavicular adenopathy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR Direct bilirubin no greater than 1.5 times ULN AST no greater than 3 times ULN Renal: Creatinine clearance at least 40 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease Pulmonary: FEV_1 at least 1 L or 35% of predicted Other: No grade 2 or greater peripheral neuropathy No weight loss of 10% or more within the past 3 months No uncontrolled infection No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer No other severe underlying disease that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic: No prior biologic therapy for NSCLC No concurrent biologic therapy No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: No prior chemotherapy for NSCLC No other concurrent chemotherapy Endocrine therapy: No prior endocrine therapy for NSCLC Radiotherapy: No prior radiotherapy for NSCLC Surgery: No prior surgery for NSCLC
Sites / Locations
- Mayo Clinic Scottsdale
- Mayo Clinic - Jacksonville
- McFarland Clinic, PC
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Hickman Cancer Center at Bixby Medical Center
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- MeritCare Bemidji
- Mayo Clinic Cancer Center
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- CCOP - MeritCare Hospital
- MeritCare Broadway
- Wood County Oncology Center
- Fremont Memorial Hospital
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care, Incorporated
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- Fulton County Health Center
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Fredericksburg Oncology, Incorporated
- Franciscan Skemp Healthcare - La Crosse Campus
Arms of the Study
Arm 1
Experimental
radiotherapy + paclitaxel + carboplatin
Patients undergo radiotherapy once daily 5 days a week for 7 weeks and 2 days (a total of 37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, once during the last week of radiotherapy, and then every 3 months for 2 years. Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for 3 years.