Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologies:
- Squamous cell carcinoma
- Adenocarcinoma (including bronchoalveolar cell)
- Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
Must meet the following criteria:
- T1-3 with N2 and selected N3*
- T4 with N0, N1, N2 and selected N3*
- M0 (no M1 patients) NOTE: *Patients with contralateral mediastinal disease (i.e., N3) are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria. Patients with ipsilateral scalene or supraclavicular disease are also eligible. Patients with contralateral hilar or supraclavicular node involvement are not eligible.
Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
Nonmeasurable lesions include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions situated in a previously irradiated area
- Patients must be considered unresectable or inoperable AND be deemed candidates for combined modality therapy by a medical oncologist and a radiation oncologist
- Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10% weight loss within the past 3 months
- Patients with tumors adjacent to a vertebral body are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria
Pleural effusions meeting the following criteria allowed:
- Effusion is transudate, cytologically negative, and non-bloody
- Effusion can be seen on the chest CT scan but not on the chest x-ray AND is too small to tap
- Effusion appears only after a thoracotomy or other invasive thoracic procedure was attempted
PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Granulocytes ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Creatinine ≤ 1.5 x upper limit of normal (ULN)
- AST < 2 x ULN
- Bilirubin ≤ ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for NSCLC
- At least 2 weeks since formal exploratory thoracotomy
- No concurrent administration of sucralfate suspension and erlotinib hydrochloride
- No concurrent intensity-modulated radiotherapy
- No concurrent hormones or other chemotherapeutic agents except steroids given for adrenal failure, hormones administered for non-disease-related conditions (e.g., insulin for diabetes), and intermittent use of dexamethasone as an antiemetic
- No concurrent palliative radiotherapy
Sites / Locations
- East Bay Radiation Oncology Center
- Valley Medical Oncology Consultants - Castro Valley
- Valley Medical Oncology
- Contra Costa Regional Medical Center
- Camino Medical Group - Treatment Center
- El Camino Hospital Cancer Center
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons, Incorporated
- CCOP - Bay Area Tumor Institute
- Larry G Strieff MD Medical Corporation
- Tom K Lee, Incorporated
- Palo Alto Medical Foundation
- Doctors Medical Center - San Pablo Campus
- Poudre Valley Radiation Oncology
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- University of Florida Shands Cancer Center
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- CCOP - Mount Sinai Medical Center
- University of Chicago Cancer Research Center
- Hematology Oncology Associates of the Quad Cities
- Menorah Medical Center
- Saint Luke's Hospital - South
- CCOP - Kansas City
- Harold Alfond Center for Cancer Care
- CancerCare of Maine at Eastern Maine Medical Center
- Greenebaum Cancer Center at University of Maryland Medical Center
- Veterans Affairs Medical Center - Baltimore
- National Naval Medical Center
- Union Hospital of Cecil County
- Boston University Cancer Research Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Genesys Regional Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Memorial Hospital
- 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
- St. John Macomb Hospital
- Regional Cancer Center at Singing River Hospital
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- St. Joseph Medical Center
- North Kansas City Hospital
- Parvin Radiation Oncology
- Heartland Hematology Oncology Associates, Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Liberty Hospital
- Heartland Regional Medical Center
- Saint Joseph Oncology, Incorporated
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
- New Hampshire Oncology - Hematology, PA - Hooksett
- Lakes Region General Hospital
- Elliot Regional Cancer Center at Elliot Hospital
- Cancer Institute of New Jersey at Cooper - Voorhees
- Veterans Affairs Medical Center - Buffalo
- CCOP - Hematology-Oncology Associates of Central New York
- Charles R. Wood Cancer Center at Glens Falls Hospital
- SUNY Upstate Medical University Hospital
- Presbyterian Cancer Center at Presbyterian Hospital
- Duke Comprehensive Cancer Center
- Kinston Medical Specialists
- Southeastern Regional Medical Center
- Granville Medical Center
- Rex Cancer Center at Rex Hospital
- Duke Health Raleigh Hospital
- Person Memorial Hospital
- Rutherford Hospital
- Iredell Memorial Hospital
- Wake Forest University Comprehensive Cancer Center
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Aultman Cancer Center at Aultman Hospital
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Danville Regional Medical Center
- Southwest Virginia Regional Cancer Center at Wellmonth Health
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Medical College of Wisconsin Cancer Center
- Veterans Affairs Medical Center - Milwaukee
Arms of the Study
Arm 1
Experimental
paclitaxel + carboplatin + radiation + erlotinib
Patients receive paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study. Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity. After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years