Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Malignant Pericardial Effusion
About this trial
This is an interventional treatment trial for Lung Adenocarcinoma focused on measuring A Phase II Randomized Study of OSI-774
Eligibility Criteria
Inclusion Criteria: Histologic documentation of primary lung adenocarcinoma including any variant thereof such as pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma; patients with non-small cell lung cancer (NSCLC) not otherwise specified (NOS) are not eligible Pathology block or unstained slides from initial or subsequent diagnosis must be available for sequencing of EGFR, K-ras, Erb-2 and B-raf; patients need to have had at least a core biopsy; patients whose diagnosis was made through a fine needle aspirate will not have sufficient material for mutational analysis and are not eligible Select stage IIIB with cytologically documented malignant pleural or pericardial effusion OR stage IV disease Patients must be chemotherapy naïve; they may not have received neo-adjuvant or adjuvant chemotherapy No prior exposure to OSI-774 (erlotinib) or other treatments targeting the human epidermal growth factor receptor (HER) family axis (e.g., trastuzumab, gefitinib, cetuximab, lapatinib, etc.) No uncontrolled central nervous system metastases (i.e., any known central nervous system [CNS] lesion which is radiographically unstable, symptomatic and/or requiring corticosteroids); patients must be >= 3 weeks beyond completing cranial irradiation and off corticosteroid therapy >= 3 weeks since prior radiation therapy >= 3 weeks since prior major surgery No treatment with an investigational agent currently or within the last 28 days Non-smoker or former light smoker; non-smoker is defined as a person who smoked =< 100 cigarettes in their lifetime while a former light smoker is a patient who smoked between > 100 cigarettes AND =< 10 pack years AND quit >= 1 year ago; this must be documented on the On-study Form (C-1405) Eastern Cooperative Oncology Group (ECOG) 0 or 1 Non-pregnant and non-nursing No dysphagia or active gastrointestinal disease or disorder that alters gastrointestinal motility or absorption; no lack of integrity of the gastrointestinal tract (e.g., a significant surgical resection of the stomach or small bowel); patients unable to swallow intact tablets must be able to swallow tablets dissolved in water Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; lesions that are considered non-measurable include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Granulocyte >= 1,500/mcl Platelet count >= 100,000/mcl Hemoglobin >= 9.0 g/dL Total bilirubin =< upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x ULN Creatinine =< 1.5 mg/dl
Sites / Locations
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- Bay Area Breast Surgeons Inc
- Valley Medical Oncology Consultants-Fremont
- Saint Rose Hospital
- Contra Costa Regional Medical Center
- El Camino Hospital
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- Valley Care Health System - Pleasanton
- Valley Medical Oncology Consultants
- University of California San Diego
- Kaiser Permanente-San Diego Mission
- Veterans Administration-San Diego Medical Center
- UCSF Medical Center-Mount Zion
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Middlesex Hospital
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- Holy Cross Hospital
- Jupiter Medical Center
- Mount Sinai Medical Center
- Memorial Health University Medical Center
- University of Chicago Comprehensive Cancer Center
- AMITA Health Adventist Medical Center
- Elkhart General Hospital
- Community Howard Regional Health
- IU Health La Porte Hospital
- Saint Joseph Regional Medical Center-Mishawaka
- Memorial Hospital of South Bend
- Northern Indiana Cancer Research Consortium
- University of Iowa/Holden Comprehensive Cancer Center
- University of Maryland/Greenebaum Cancer Center
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Union Hospital of Cecil County
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- Mass General/North Shore Cancer Center
- Cape Cod Hospital
- Lowell General Hospital
- South Shore Hospital
- Lakeland Medical Center Saint Joseph
- University of Minnesota/Masonic Cancer Center
- Missouri Cancer Associates
- Veterans Administration
- University of Missouri - Ellis Fischel
- Capital Region Medical Center
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Center for Cancer Care and Research
- CHI Health Saint Francis
- Great Plains Health Callahan Cancer Center
- University of Nebraska Medical Center
- University Medical Center of Southern Nevada
- Saint Joseph Hospital
- Cooper Hospital University Medical Center
- Rutgers Cancer Institute of New Jersey
- Roswell Park Cancer Institute
- Hematology Oncology Associates of Central New York-East Syracuse
- Northwell Health NCORP
- North Shore University Hospital
- Long Island Jewish Medical Center
- Ralph Lauren Center for Cancer Care and Prevention
- Memorial Sloan Kettering Cancer Center
- Saint Joseph's Hospital Health Center
- State University of New York Upstate Medical University
- UNC Lineberger Comprehensive Cancer Center
- Novant Health Presbyterian Medical Center
- Duke University Medical Center
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- Margaret R Pardee Memorial Hospital
- Vidant Oncology-Kinston
- Wilson Medical Center
- Ohio State University Comprehensive Cancer Center
- University of Oklahoma Health Sciences Center
- Cancer Care Associates
- Memorial Hospital of Rhode Island
- Rhode Island Hospital
- Miriam Hospital
- Roper Hospital
- McLeod Regional Medical Center
- Saint Francis Hospital
- Greenville Memorial Hospital
- Greenville Health System Cancer Institute-Eastside
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont and State Agricultural College
- Rappahannock General Hospital
- Virginia Commonwealth University/Massey Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (erlotinib hydrochloride)
Arm II (erlotinib hydrochloride, paclitaxel, carboplatin)
Patients receive erlotinib hydrochloride PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive erlotinib hydrochloride as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of treatment, patients may continue to receive erlotinib hydrochloride alone as above.