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Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3 |
|
| Arm B | Experimental | Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous topotecan/cisplatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Median overall survival time of participants | Up to 1 year after randomization of the last patient |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with one year survival rate of the participants | Up to 1 year after randomization of the last patient | |
| Median time of disease progression | up to 1 year after randomization of the last patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bludesch | A-6719 | Austria | |||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 5, 2018 | |
| Unrelease | Aug 15, 2018 |
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|
| Intravenous etoposide/cisplatin | Drug | 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. |
|
| Median time to event (progressive disease or death) of participants | Up to 1 year after randomization of the last patient |
| Median time to response to chemotherapy | Up to 1 year after randomization of the last patient |
| Median response duration | Up to 1 year after randomization of the last patient |
| Number of participants with objective response | Up to 1 year after randomization of the last patient |
| Mean lung cancer symptom score (LCSS) | Up to 18 weeks |
| Mean eastern cooperative oncology group (ECOG) score | Up to 18 weeks |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to 1 year after randomization of the last patient |
| Mean change from Baseline in hemoglobin value | Baseline and up to 18 weeks |
| Mean change from Baseline in leukocytes, neutrophils and platelets count | Baseline and up to 18 weeks |
| Mean change from Baseline in red blood cells (RBCs) | Baseline and up to 18 weeks |
| Mean change from Baseline in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase and Lactate dehydrogenase (LDH) | Baseline and up to 18 weeks |
| Mean change from Baseline in Blood urea nitrogen (BUN), Potassium, Sodium and urea | Baseline and up to 18 weeks |
| Mean change from Baseline in Creatinine and Total bilirubin | Baseline and up to 18 weeks |
| Mean change from Baseline in Creatinine clearance |
| Mean change from Baseline in total protein | Baseline and up to 18 weeks |
| Number of participants with abnormal urinalysis results |
| Mean change from Baseline in weight | Baseline and up to 18 weeks |
| Mean change from Baseline in Body surface area | Baseline and up to 18 weeks |
| Klagenfurt |
| A-9020 |
| Austria |
| GSK Investigational Site | Linz | A-4020 | Austria |
| GSK Investigational Site | Vienna | A-1140 | Austria |
| GSK Investigational Site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| GSK Investigational Site | Karlsruhe | Baden-Wurttemberg | 76137 | Germany |
| GSK Investigational Site | Löwenstein | Baden-Wurttemberg | 74245 | Germany |
| GSK Investigational Site | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| GSK Investigational Site | Wangen | Baden-Wurttemberg | 88239 | Germany |
| GSK Investigational Site | Bayreuth | Bavaria | 95445 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80336 | Germany |
| GSK Investigational Site | Nuremberg | Bavaria | 90340 | Germany |
| GSK Investigational Site | Passau | Bavaria | 94032 | Germany |
| GSK Investigational Site | Regensburg | Bavaria | 93049 | Germany |
| GSK Investigational Site | Rosenheim | Bavaria | 83022 | Germany |
| GSK Investigational Site | Cottbus | Brandenburg | 03048 | Germany |
| GSK Investigational Site | Frankfurt (Oder) | Brandenburg | 15236 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 21075 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22043 | Germany |
| GSK Investigational Site | Bremen | Free Hanseatic City of Bremen | 28325 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60431 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 65929 | Germany |
| GSK Investigational Site | Giessen | Hesse | 35392 | Germany |
| GSK Investigational Site | Greifenstein | Hesse | 35753 | Germany |
| GSK Investigational Site | Kassel | Hesse | 34125 | Germany |
| GSK Investigational Site | Limburg an der Lahn | Hesse | 65549 | Germany |
| GSK Investigational Site | Marburg | Hesse | 35043 | Germany |
| GSK Investigational Site | Offenbach | Hesse | 63069 | Germany |
| GSK Investigational Site | Wiesbaden | Hesse | 65199 | Germany |
| GSK Investigational Site | Göttingen | Lower Saxony | 37075 | Germany |
| GSK Investigational Site | Leer | Lower Saxony | 26789 | Germany |
| GSK Investigational Site | Stade | Lower Saxony | 21680 | Germany |
| GSK Investigational Site | Greifswald | Mecklenburg-Vorpommern | 17487 | Germany |
| GSK Investigational Site | Neubrandenburg | Mecklenburg-Vorpommern | 17036 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18059 | Germany |
| GSK Investigational Site | Stralsund | Mecklenburg-Vorpommern | 18437 | Germany |
| GSK Investigational Site | Waren | Mecklenburg-Vorpommern | 17192 | Germany |
| GSK Investigational Site | Bielefeld | North Rhine-Westphalia | 33604 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44791 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53111 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53113 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53177 | Germany |
| GSK Investigational Site | Coesfeld | North Rhine-Westphalia | 48653 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50924 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50931 | Germany |
| GSK Investigational Site | Dorsten | North Rhine-Westphalia | 46282 | Germany |
| GSK Investigational Site | Duisburg | North Rhine-Westphalia | 47166 | Germany |
| GSK Investigational Site | Duisburg | North Rhine-Westphalia | 47228 | Germany |
| GSK Investigational Site | Hamm | North Rhine-Westphalia | 59071 | Germany |
| GSK Investigational Site | Hemer | North Rhine-Westphalia | 58675 | Germany |
| GSK Investigational Site | Herne | North Rhine-Westphalia | 44625 | Germany |
| GSK Investigational Site | Krefeld | North Rhine-Westphalia | 47798 | Germany |
| GSK Investigational Site | Oberhausen | North Rhine-Westphalia | 46145 | Germany |
| GSK Investigational Site | Velbert | North Rhine-Westphalia | 42551 | Germany |
| GSK Investigational Site | Wuppertal | North Rhine-Westphalia | 42283 | Germany |
| GSK Investigational Site | Koblenz | Rhineland-Palatinate | 56073 | Germany |
| GSK Investigational Site | Ludwigshafen am Rhein | Rhineland-Palatinate | 67063 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54290 | Germany |
| GSK Investigational Site | Chemnitz | Saxony | 09113 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04207 | Germany |
| GSK Investigational Site | Plauen | Saxony | 08529 | Germany |
| GSK Investigational Site | Halle | Saxony-Anhalt | 06114 | Germany |
| GSK Investigational Site | Magdeburg | Saxony-Anhalt | 39120 | Germany |
| GSK Investigational Site | Borstel | Schleswig-Holstein | 23845 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24939 | Germany |
| GSK Investigational Site | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 12200 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 12559 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13125 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13353 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13585 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 14089 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 14109 | Germany |
| GSK Investigational Site | Erfurt | Thuringia | 99089 | Germany |
| GSK Investigational Site | Jena | Thuringia | 07747 | Germany |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 5, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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