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Sponsored by: |
OSI Pharmaceuticals |
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Information provided by: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00085839 |
The purpose of this study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated NSCLC and an ECOG PS of 2. The study will also evaluate the safety of single-agent erlotnib in this patient population.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) Drug: Combination carboplatin and paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status |
Estimated Enrollment: | 102 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Erlotinib tablets administered PO, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
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Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Erlotinib tablets administered PO, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
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2: Active Comparator
Paclitaxel 200 mg/m2 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
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Drug: Combination carboplatin and paclitaxel
Paclitaxel 200 mg/m2 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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Sharp Clinical Oncology Research | |
San Diego, California, United States, 92123 | |
California Cancer Care, Inc. | |
Greenbrae, California, United States, 94904 | |
United States, Florida | |
Mount Sinai Cancer Center | |
Miami Beach, Florida, United States, 33140 | |
University of Miami | |
Miami, Florida, United States, 33136 | |
Holy Cross Hospital | |
Fort Lauderdale, Florida, United States, 33308 | |
United States, Illinois | |
Oncology/Hematology Associates of Central Illinois | |
Peoria, Illinois, United States, 61615 | |
Evanston Northwestern Healthcare | |
Evanston, Illinois, United States, 60201 | |
United States, Kentucky | |
Norton Healthcare, Inc. | |
Louisville, Kentucky, United States, 40202 | |
United States, Maryland | |
Maryland Hematology/Oncology Associates | |
Baltimore, Maryland, United States, 21237 | |
United States, Nevada | |
VA Sierra Nevada Health Care System | |
Reno, Nevada, United States, 89502 | |
United States, New York | |
Weill Medical College of Cornell University | |
New York, New York, United States, 10021 | |
United States, North Dakota | |
FEK Addo, PC | |
Bismarck, North Dakota, United States, 58503 | |
United States, Ohio | |
Gabrail Cancer Center | |
Canton, Ohio, United States, 44718 | |
Ohio State University | |
Columbus, Ohio, United States, 43210-1240 | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, South Carolina | |
Charleston Hematology Oncology | |
Charleston, South Carolina, United States, 29403 | |
United States, Tennessee | |
East Tennessee Oncology/Hematology, PC | |
Knoxville, Tennessee, United States, 37920 | |
Sarah Cannon Cancer Center | |
Nashville, Tennessee, United States, 37203 |
Responsible Party: | OSI Pharmaceuticals, Inc. ( Karsten Witt, MD ) |
Study ID Numbers: | OSI-774-201, Tarceva Performance Status 2 |
Study First Received: | June 15, 2004 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00085839 |
Health Authority: | United States: Food and Drug Administration |
Tarceva NSCLC EGFR ECOG Performance Status 2 |
erlotinib Non-Small Cell Lung Cancer OSI-774 |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms |
Lung Diseases Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |