Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
NCT ID: NCT00085839
Last Updated: 2012-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2004-02-29
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Erlotinib
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Tarceva (Trademark) (erlotinib HCl, OSI-774)
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Standard Chemotherapy
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
Combination carboplatin and paclitaxel
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
Interventions
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Tarceva (Trademark) (erlotinib HCl, OSI-774)
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Combination carboplatin and paclitaxel
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
Eligibility Criteria
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Inclusion Criteria
* No prior chemotherapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status 2
* Clinically or radiologically measurable disease per RECIST criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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OSI Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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California Cancer Care, Inc.
Greenbrae, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
University of Miami
Miami, Florida, United States
Mount Sinai Cancer Center
Miami Beach, Florida, United States
Evanston Northwestern Healthcare
Evanston, Illinois, United States
Oncology/Hematology Associates of Central Illinois
Peoria, Illinois, United States
Norton Healthcare, Inc.
Louisville, Kentucky, United States
Maryland Hematology/Oncology Associates
Baltimore, Maryland, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
Weill Medical College of Cornell University
New York, New York, United States
FEK Addo, PC
Bismarck, North Dakota, United States
Gabrail Cancer Center
Canton, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Charleston Hematology Oncology
Charleston, South Carolina, United States
East Tennessee Oncology/Hematology, PC
Knoxville, Tennessee, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Countries
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References
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Lilenbaum R, Axelrod R, Thomas S, Dowlati A, Seigel L, Albert D, Witt K, Botkin D. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol. 2008 Feb 20;26(6):863-9. doi: 10.1200/JCO.2007.13.2720.
Related Links
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OSI Pharmaceuticals website
Other Identifiers
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OSI-774-201
Identifier Type: -
Identifier Source: org_study_id