Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
Non-Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Tarceva, NSCLC, EGFR, ECOG Performance Status 2, erlotinib, Non-Small Cell Lung Cancer, OSI-774
Eligibility Criteria
Inclusion Criteria: Stage IIIB or IV Nonsmall cell lung cancer (NSCLC) No prior chemotherapy Eastern Cooperative Oncology Group (ECOG) Performance Status 2 Clinically or radiologically measurable disease per RECIST criteria Exclusion Criteria: Gastro-intestinal abnormalities Any concurrent anticancer therapy Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind Other active malignancies Uncontrolled brain metastases Severe abnormalities of the cornea Significant cardiac disease
Sites / Locations
- California Cancer Care, Inc.
- Sharp Clinical Oncology Research
- Holy Cross Hospital
- Mount Sinai Cancer Center
- University of Miami
- Evanston Northwestern Healthcare
- Oncology/Hematology Associates of Central Illinois
- Norton Healthcare, Inc.
- Maryland Hematology/Oncology Associates
- VA Sierra Nevada Health Care System
- Weill Medical College of Cornell University
- FEK Addo, PC
- Gabrail Cancer Center
- University Hospitals of Cleveland
- Ohio State University
- Thomas Jefferson University Hospital
- Charleston Hematology Oncology
- East Tennessee Oncology/Hematology, PC
- Sarah Cannon Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Erlotinib
Standard Chemotherapy
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles