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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00320359 |
Purpose
Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Drug: Intravenous etoposide/cisplatin Drug: Intravenous topotecan/cisplatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer |
| Enrollment: | 700 |
| Study Start Date: | August 2002 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm A: Active Comparator
Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3
|
Drug: Intravenous etoposide/cisplatin
Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 1. Cisplatin should be given simultaneously to post-hydration to ensure a high volume fluid. Etoposide 100 mg/m2 should be administered after cisplatin intravenously over a period not less than 30 minutes on days 1 -3. |
|
Arm B: Experimental
Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5
|
Drug: Intravenous topotecan/cisplatin
Topotecan 1 mg/m2 should be administered intravenously over a period of 30 minutes on days 1-5. Then a 30 minute saline flush should be administered followed by the cisplatin on day 5. Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 5 after topotecan. |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| Austria | |
| GSK Investigational Site | |
| Linz, Austria, A-4020 | |
| GSK Investigational Site | |
| Bludesch, Austria, A-6719 | |
| GSK Investigational Site | |
| Klagenfurt, Austria, A-9020 | |
| GSK Investigational Site | |
| Vienna, Austria, A-1140 | |
| Germany | |
| GSK Investigational Site | |
| Berlin, Germany, 14089 | |
| GSK Investigational Site | |
| Berlin, Germany, 12559 | |
| GSK Investigational Site | |
| Berlin, Germany, 13353 | |
| GSK Investigational Site | |
| Berlin, Germany, 13578 | |
| GSK Investigational Site | |
| Berlin, Germany, 10117 | |
| GSK Investigational Site | |
| Berlin, Germany, 13125 | |
| GSK Investigational Site | |
| Berlin, Germany, 12200 | |
| GSK Investigational Site | |
| Berlin, Germany, 14109 | |
| GSK Investigational Site | |
| Bremen, Germany, 28325 | |
| GSK Investigational Site | |
| Hamburg, Germany, 20246 | |
| GSK Investigational Site | |
| Hamburg, Germany, 21075 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22043 | |
| Germany, Baden-Wuerttemberg | |
| GSK Investigational Site | |
| Karlsruhe, Baden-Wuerttemberg, Germany, 76137 | |
| GSK Investigational Site | |
| Freiburg, Baden-Wuerttemberg, Germany, 79106 | |
| GSK Investigational Site | |
| Loewenstein, Baden-Wuerttemberg, Germany, 74245 | |
| GSK Investigational Site | |
| Mannheim, Baden-Wuerttemberg, Germany, 68167 | |
| GSK Investigational Site | |
| Wangen, Baden-Wuerttemberg, Germany, 88239 | |
| Germany, Bayern | |
| GSK Investigational Site | |
| Rosenheim, Bayern, Germany, 83022 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80336 | |
| GSK Investigational Site | |
| Regensburg, Bayern, Germany, 93049 | |
| GSK Investigational Site | |
| Nuernberg, Bayern, Germany, 90340 | |
| GSK Investigational Site | |
| Passau, Bayern, Germany, 94032 | |
| GSK Investigational Site | |
| Bayreuth, Bayern, Germany, 95445 | |
| Germany, Brandenburg | |
| GSK Investigational Site | |
| Cottbus, Brandenburg, Germany, 03048 | |
| GSK Investigational Site | |
| Frankfurt/Oder, Brandenburg, Germany, 15236 | |
| Germany, Hessen | |
| GSK Investigational Site | |
| Frankfurt, Hessen, Germany, 60431 | |
| GSK Investigational Site | |
| Giessen, Hessen, Germany, 35392 | |
| GSK Investigational Site | |
| Offenbach, Hessen, Germany, 63069 | |
| GSK Investigational Site | |
| Limburg, Hessen, Germany, 65549 | |
| GSK Investigational Site | |
| Wiesbaden, Hessen, Germany, 65199 | |
| GSK Investigational Site | |
| Marburg, Hessen, Germany, 35043 | |
| GSK Investigational Site | |
| Greifenstein, Hessen, Germany, 35753 | |
| GSK Investigational Site | |
| Kassel, Hessen, Germany, 34125 | |
| GSK Investigational Site | |
| Frankfurt, Hessen, Germany, 65929 | |
| Germany, Mecklenburg-Vorpommern | |
| GSK Investigational Site | |
| Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036 | |
| GSK Investigational Site | |
| Stralsund, Mecklenburg-Vorpommern, Germany, 18437 | |
| GSK Investigational Site | |
| Plauen, Mecklenburg-Vorpommern, Germany, 08529 | |
| GSK Investigational Site | |
| Greifswald, Mecklenburg-Vorpommern, Germany, 17487 | |
| GSK Investigational Site | |
| Rostock, Mecklenburg-Vorpommern, Germany, 18057 | |
| GSK Investigational Site | |
| Waren, Mecklenburg-Vorpommern, Germany, 17192 | |
| GSK Investigational Site | |
| Rostock, Mecklenburg-Vorpommern, Germany, 18059 | |
| Germany, Niedersachsen | |
| GSK Investigational Site | |
| Goettingen, Niedersachsen, Germany, 37075 | |
| GSK Investigational Site | |
| Stade, Niedersachsen, Germany, 21680 | |
| GSK Investigational Site | |
| Leer, Niedersachsen, Germany, 26789 | |
| Germany, Nordrhein-Westfalen | |
| GSK Investigational Site | |
| Duisburg, Nordrhein-Westfalen, Germany, 47166 | |
| GSK Investigational Site | |
| Bonn, Nordrhein-Westfalen, Germany, 53113 | |
| GSK Investigational Site | |
| Koeln, Nordrhein-Westfalen, Germany, 50931 | |
| GSK Investigational Site | |
| Wuppertal, Nordrhein-Westfalen, Germany, 42283 | |
| GSK Investigational Site | |
| Dorsten, Nordrhein-Westfalen, Germany, 46282 | |
| GSK Investigational Site | |
| Bochum, Nordrhein-Westfalen, Germany, 44791 | |
| GSK Investigational Site | |
| Koeln, Nordrhein-Westfalen, Germany, 50924 | |
| GSK Investigational Site | |
| Hemer, Nordrhein-Westfalen, Germany, 58675 | |
| GSK Investigational Site | |
| Bonn, Nordrhein-Westfalen, Germany, 53177 | |
| GSK Investigational Site | |
| Velbert, Nordrhein-Westfalen, Germany, 42551 | |
| GSK Investigational Site | |
| Oberhausen, Nordrhein-Westfalen, Germany, 46145 | |
| GSK Investigational Site | |
| Hamm, Nordrhein-Westfalen, Germany, 59071 | |
| GSK Investigational Site | |
| Krefeld, Nordrhein-Westfalen, Germany, 47798 | |
| GSK Investigational Site | |
| Coesfeld, Nordrhein-Westfalen, Germany, 48653 | |
| GSK Investigational Site | |
| Bonn, Nordrhein-Westfalen, Germany, 53111 | |
| GSK Investigational Site | |
| Bielefeld, Nordrhein-Westfalen, Germany, 33604 | |
| GSK Investigational Site | |
| Duisburg, Nordrhein-Westfalen, Germany, 47228 | |
| GSK Investigational Site | |
| Herne, Nordrhein-Westfalen, Germany, 44625 | |
| Germany, Rheinland-Pfalz | |
| GSK Investigational Site | |
| Trier, Rheinland-Pfalz, Germany, 54290 | |
| GSK Investigational Site | |
| Koblenz, Rheinland-Pfalz, Germany, 56073 | |
| GSK Investigational Site | |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| GSK Investigational Site | |
| Ludwigshafen, Rheinland-Pfalz, Germany, 67063 | |
| Germany, Sachsen | |
| GSK Investigational Site | |
| Chemnitz, Sachsen, Germany, 09113 | |
| GSK Investigational Site | |
| Halle/Saale, Sachsen, Germany, 06114 | |
| GSK Investigational Site | |
| Leipzig, Sachsen, Germany, 04207 | |
| Germany, Sachsen-Anhalt | |
| GSK Investigational Site | |
| Magdeburg, Sachsen-Anhalt, Germany, 39120 | |
| Germany, Schleswig-Holstein | |
| GSK Investigational Site | |
| Borstel, Schleswig-Holstein, Germany, 23845 | |
| GSK Investigational Site | |
| Grosshansdorf, Schleswig-Holstein, Germany, 22927 | |
| GSK Investigational Site | |
| Flensburg, Schleswig-Holstein, Germany, 24939 | |
| Germany, Thueringen | |
| GSK Investigational Site | |
| Jena, Thueringen, Germany, 07747 | |
| GSK Investigational Site | |
| Erfurt, Thueringen, Germany, 99089 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 104864-A/479 |
| Study First Received: | May 1, 2006 |
| Last Updated: | August 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00320359 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Small Cell Lung Cancer Extensive Disease First-line Cisplatin topotecan etoposide |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Etoposide phosphate Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Etoposide Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Enzyme Inhibitors Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Lung Diseases Adenocarcinoma Topotecan Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
