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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00316186 |
This study was designed to find the safest and most effective dose of a combination of two chemotherapy drugs, Hycamtin® (topotecan) and Paraplatin® (carboplatin), in people with extensive disease small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Small Cell Lung Cancer |
Drug: topotecan Drug: carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | An Open-Label Phase II Study of Weekly Intravenous Hycamtin and Carboplatin as First-Line Treatment of Chemonaive Subjects With Extensive Disease Small Cell Lung Cancer |
Estimated Enrollment: | 65 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
CrCl may be calculated using the Cockcroft-Gault formula:
CrCl (ml/min) = Q x (140-age [yr]) x body wt [kg] 72 x serum creatinine [mg/dl] Q = 0.85 for females Q = 1.0 for males CrCl (ml/min) = K x (140-age [yr]) x body wt [kg] Serum creatinine [mol/L] K = 1.0 for females K = 1.23 for males
Exclusion criteria:
United States, Arizona | |
GSK Clinical Trials Call Center | |
Tucson, Arizona, United States, 85723 | |
GSK Clinical Trials Call Center | |
Tuscon, Arizona, United States, 85715 | |
United States, California | |
GSK Clinical Trials Call Center | |
Concord, California, United States, 94520 | |
GSK Clinical Trials Call Center | |
Sacramento, California, United States, 95819 | |
United States, Florida | |
GSK Clinical Trials Call Center | |
Boca Raton, Florida, United States, 33486 | |
GSK Clinical Trials Call Center | |
Hollywood, Florida, United States, 33021 | |
GSK Clinical Trials Call Center | |
West Palm Beach, Florida, United States, 33401 | |
United States, Indiana | |
GSK Clinical Trials Call Center | |
Munster, Indiana, United States, 46321 | |
United States, Louisiana | |
GSK Clinical Trials Call Center | |
Metairie, Louisiana, United States, 70006 | |
United States, Massachusetts | |
GSK Clinical Trials Call Center | |
Worcester, Massachusetts, United States, 01608 | |
United States, Missouri | |
GSK Clinical Trials Call Center | |
St. Louis, Missouri, United States, 63141 | |
United States, Nevada | |
GSK Clinical Trials Call Center | |
Henderson, Nevada, United States, 89014 | |
United States, New Jersey | |
GSK Clinical Trials Call Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, New Mexico | |
GSK Clinical Trials Call Center | |
Albuquerque, New Mexico, United States, 87109 | |
United States, New York | |
GSK Clinical Trials Call Center | |
Rochester, New York, United States, 14623 | |
GSK Clinical Trials Call Center | |
Bronx, New York, United States, 10467 | |
United States, Texas | |
GSK Clinical Trials Call Center | |
Dallas, Texas, United States, 75246 | |
GSK Clinical Trials Call Center | |
Ft. Worth, Texas, United States, 76104 | |
United States, Virginia | |
GSK Clinical Trials Call Center | |
Richmond, Virginia, United States, 23230 |
Study Chair: | GSK Clinical trials, MD | GlaxoSmithKline |
Study ID Numbers: | 104864/903 |
Study First Received: | April 19, 2006 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00316186 |
Health Authority: | United States: Food and Drug Administration |
Lung cancer small cell lung cancer first-line extensive disease |
HYCAMTIN chemonaive untreated |
Thoracic Neoplasms Carcinoma, Neuroendocrine Carboplatin Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Topotecan Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Neoplasms, Nerve Tissue Enzyme Inhibitors Pharmacologic Actions |