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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00043927 |
Purpose
This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Drug: topotecan/cisplatin Drug: etoposide/cisplatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-Naive Patients With Extensive Disease-Small Cell Lung Cancer. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| GSK Clinical Trials Call Center | |
| Hoover, Alabama, United States, 35216 | |
| United States, California | |
| GSK Clinical Trials Call Center | |
| Sacramento, California, United States, 95816-5616 | |
| GSK Clinical Trials Call Center | |
| Greenbrae, California, United States, 94904 | |
| GSK Clinical Trials Call Center | |
| Poway, California, United States, 92064 | |
| GSK Clinical Trials Call Center | |
| Vista, California, United States, 92083 | |
| GSK Clinical Trials Call Center | |
| San Diego, California, United States, 92121 | |
| GSK Clinical Trials Call Center | |
| Soquel, California, United States, 95073 | |
| GSK Clinical Trials Call Center | |
| Chula Vista, California, United States, 91911 | |
| GSK Clinical Trials Call Center | |
| San Diego, California, United States, 92102-8421 | |
| GSK Clinical Trials Call Center | |
| Fountain Valley, California, United States, 92708 | |
| GSK Clinical Trials Call Center | |
| Rancho Mirage, California, United States, 92270 | |
| United States, Colorado | |
| GSK Clinical Trials Call Center | |
| Colorado Springs, Colorado, United States, 80909 | |
| United States, Connecticut | |
| GSK Clinical Trials Call Center | |
| Norwich, Connecticut, United States, 06360 | |
| United States, District of Columbia | |
| GSK Clinical Trials Call Center | |
| Washington, District of Columbia, United States, 20307-5001 | |
| United States, Florida | |
| GSK Clinical Trials Call Center | |
| Tarpon Springs, Florida, United States, 34689 | |
| GSK Clinical Trials Call Center | |
| Ocala, Florida, United States, 34471 | |
| GSK Clinical Trials Call Center | |
| Pensacola, Florida, United States, 32501 | |
| GSK Clinical Trials Call Center | |
| Gainesville, Florida, United States, 32610 | |
| GSK Clinical Trials Call Center | |
| Miami Shores, Florida, United States, 33138 | |
| United States, Georgia | |
| GSK Clinical Trials Call Center | |
| Atlanta, Georgia, United States, 30308 | |
| GSK Clinical Trials Call Center | |
| Decatur, Georgia, United States, 30033 | |
| GSK Clinical Trials Call Center | |
| Atlanta, Georgia, United States, 30030 | |
| GSK Clinical Trials Call Center | |
| Augusta, Georgia, United States, 30912 | |
| GSK Clinical Trials Call Center | |
| Atlanta, Georgia, United States, 30328 | |
| GSK Clinical Trials Call Center | |
| Cummings, Georgia, United States, 30040 | |
| GSK Clinical Trials Call Center | |
| Atlanta, Georgia, United States, 30335 | |
| United States, Illinois | |
| GSK Clinical Trials Call Center | |
| Park Ridge, Illinois, United States, 60068 | |
| GSK Clinical Trials Call Center | |
| Elk Grove Village, Illinois, United States, 60007 | |
| GSK Clinical Trials Call Center | |
| Chicago, Illinois, United States, 60612 | |
| GSK Clinical Trials Call Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| GSK Clinical Trials Call Center | |
| Aurora, Illinois, United States, 60506 | |
| United States, Indiana | |
| GSK Clinical Trials Call Center | |
| Evansville, Indiana, United States, 47713 | |
| GSK Clinical Trials Call Center | |
| South Bend, Indiana, United States, 46601 | |
| United States, Louisiana | |
| GSK Clinical Trials Call Center | |
| New Orleans, Louisiana, United States, 70112 | |
| GSK Clinical Trials Call Center | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Maryland | |
| GSK Clinical Trials Call Center | |
| Frederick, Maryland, United States, 21701 | |
| United States, Massachusetts | |
| GSK Clinical Trials Call Center | |
| Pittsfield, Massachusetts, United States, 01201 | |
| United States, Minnesota | |
| GSK Clinical Trials Call Center | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Missouri | |
| GSK Clinical Trials Call Center | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nevada | |
| GSK Clinical Trials Call Center | |
| Reno, Nevada, United States, 89502 | |
| United States, New Jersey | |
| GSK Clinical Trials Call Center | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New Mexico | |
| GSK Clinical Trials Call Center | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| GSK Clinical Trials Call Center | |
| Valhalla, New York, United States, 10595 | |
| GSK Clinical Trials Call Center | |
| New York, New York, United States, 10021 | |
| GSK Clinical Trials Call Center | |
| New York, New York, United States, 10032 | |
| GSK Clinical Trials Call Center | |
| Rochester, New York, United States, 14623 | |
| GSK Clinical Trials Call Center | |
| Albany, New York, United States, 12208 | |
| United States, North Dakota | |
| GSK Clinical Trials Call Center | |
| Bismarck, North Dakota, United States, 58501 | |
| GSK Clinical Trials Call Center | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| GSK Clinical Trials Call Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| GSK Clinical Trials Call Center | |
| Columbus, Ohio, United States, 43222 | |
| United States, Oregon | |
| GSK Clinical Trials Call Center | |
| Portland, Oregon, United States, 97232-2099 | |
| United States, Pennsylvania | |
| GSK Clinical Trials Call Center | |
| Lemoyne, Pennsylvania, United States, 17043 | |
| GSK Clinical Trials Call Center | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| GSK Clinical Trials Call Center | |
| Limerick, Pennsylvania, United States, 19468 | |
| United States, South Carolina | |
| GSK Clinical Trials Call Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| GSK Clinical Trials Call Center | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Tennessee | |
| GSK Clinical Trials Call Center | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| GSK Clinical Trials Call Center | |
| Fort Worth, Texas, United States, 76104 | |
| GSK Clinical Trials Call Center | |
| Houston, Texas, United States, 77060 | |
| United States, Virginia | |
| GSK Clinical Trials Call Center | |
| Abingdon, Virginia, United States, 24211 | |
| GSK Clinical Trials Call Center | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| GSK Clinical Trials Call Center | |
| Yakima, Washington, United States, 98902 | |
| GSK Clinical Trials Call Center | |
| Olympia, Washington, United States, 98506 | |
| United States, West Virginia | |
| GSK Clinical Trials Call Center | |
| Morgantown, West Virginia, United States, 26506 | |
| United States, Wisconsin | |
| GSK Clinical Trials Call Center | |
| Madison, Wisconsin, United States, 53792 | |
| United States, Wyoming | |
| GSK Clinical Trials Call Center | |
| Laramie, Wyoming, United States, 82070 | |
| Austria | |
| GSK Clinical Trials Call Center | |
| Vienna, Austria, A-1090 | |
| GSK Clinical Trials Call Center | |
| Vienna, Austria, A-1130 | |
| GSK Clinical Trials Call Center | |
| Vienna, Austria, A-1140 | |
| Belgium | |
| GSK Clinical Trials Call Center | |
| Leuven, Belgium, 3000 | |
| GSK Clinical Trials Call Center | |
| Charleroi, Belgium, 6000 | |
| GSK Clinical Trials Call Center | |
| Edegem, Belgium, 2650 | |
| GSK Clinical Trials Call Center | |
| Luxembourg, Belgium, 1210 | |
| GSK Clinical Trials Call Center | |
| Haine-Saint- Paul, Belgium, 7100 | |
| GSK Clinical Trials Call Center | |
| Liege, Belgium, 4000 | |
| Brazil | |
| GSK Clinical Trials Call Center | |
| Fortaleza, Brazil, 60430-230 | |
| GSK Clinical Trials Call Center | |
| Salvador, Brazil, 41920-000 | |
| GSK Clinical Trials Call Center | |
| Sao Paulo, Brazil, 04023-062 | |
| GSK Clinical Trials Call Center | |
| Porto Alegre, Brazil, 90035-003 | |
| GSK Clinical Trials Call Center | |
| Belo Horizonte, Brazil, 30140-083 | |
| GSK Clinical Trials Call Center | |
| Rio de Janeiro, Brazil, 20230-130 | |
| GSK Clinical Trials Call Center | |
| Caxias do Sul, Brazil, 95010-060 | |
| GSK Clinical Trials Call Center | |
| Sao Paulo, Brazil, 05403-900 | |
| GSK Clinical Trials Call Center | |
| Porto Alegre, Brazil, 90020-090 | |
| Bulgaria | |
| GSK Clinical Trials Call Center | |
| Bourgas, Bulgaria, 8000 | |
| GSK Clinical Trials Call Center | |
| Sofia, Bulgaria, 1156 | |
| GSK Clinical Trials Call Center | |
| Sofia, Bulgaria, 1000/1527 | |
| GSK Clinical Trials Call Center | |
| Plovdiv, Bulgaria, 4000 | |
| GSK Clinical Trials Call Center | |
| Varna, Bulgaria, 9010 | |
| Canada, Alberta | |
| GSK Clinical Trials Call Center | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| GSK Clinical Trials Call Center | |
| Edmonton, Alberta, Canada, T6G 1E2 | |
| Canada, Manitoba | |
| GSK Clinical Trials Call Center | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Nova Scotia | |
| GSK Clinical Trials Call Center | |
| Sydney, Nova Scotia, Canada, B1P 1P3 | |
| Canada, Ontario | |
| GSK Clinical Trials Call Center | |
| Weston, Ontario, Canada, M9N 1N8 | |
| GSK Clinical Trials Call Center | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| GSK Clinical Trials Call Center | |
| Sault Sainte Marie, Ontario, Canada, P6B 1Y5 | |
| GSK Clinical Trials Call Center | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| GSK Clinical Trials Call Center | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| GSK Clinical Trials Call Center | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| GSK Clinical Trials Call Center | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| GSK Clinical Trials Call Center | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| GSK Clinical Trials Call Center | |
| Peterborough, Ontario, Canada, K9H 7B6 | |
| Canada, Quebec | |
| GSK Clinical Trials Call Center | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| GSK Clinical Trials Call Center | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| GSK Clinical Trials Call Center | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| GSK Clinical Trials Call Center | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| GSK Clinical Trials Call Center | |
| Sainte-Foy, Quebec, Canada, G1V 4G5 | |
| Chile | |
| GSK Clinical Trials Call Center | |
| Santiago, Chile | |
| China | |
| GSK Clinical Trials Call Center | |
| Beijing, China, 100036 | |
| GSK Clinical Trials Call Center | |
| Shanghai, China, 200433 | |
| GSK Clinical Trials Call Center | |
| Xian, China, 710061 | |
| GSK Clinical Trials Call Center | |
| Wangfujing, China, 100730 | |
| Costa Rica | |
| GSK Clinical Trials Call Center | |
| San Jose, Costa Rica | |
| Czech Republic | |
| GSK Clinical Trials Call Center | |
| Olomouc, Czech Republic, 775 25 | |
| GSK Clinical Trials Call Center | |
| Hradec Kralove, Czech Republic, 500 05 | |
| GSK Clinical Trials Call Center | |
| Praha, Czech Republic, 121 00 | |
| GSK Clinical Trials Call Center | |
| Praha, Czech Republic, 150 05 | |
| GSK Clinical Trials Call Center | |
| Plzen, Czech Republic, 305 99 | |
| Estonia | |
| GSK Clinical Trials Call Center | |
| Tallinn, Estonia, 11619 | |
| Finland | |
| GSK Clinical Trials Call Center | |
| Helsinki, Finland, 29 | |
| GSK Clinical Trials Call Center | |
| Kangasala, Finland, 36280 | |
| GSK Clinical Trials Call Center | |
| Oulu, Finland, 90029 | |
| France | |
| GSK Clinical Trials Call Center | |
| Caen, France, 14076 | |
| GSK Clinical Trials Call Center | |
| Vesoul, France, 70014 | |
| GSK Clinical Trials Call Center | |
| Calais Cedex, France, 62107 | |
| GSK Clinical Trials Call Center | |
| Strasbourg, France, 67091 | |
| Germany | |
| GSK Clinical Trials Call Center | |
| Grosshansdorf, Germany, 22927 | |
| Germany, Baden-Wurttemberg | |
| GSK Clinical Trials Call Center | |
| Heidelberg, Baden-Wurttemberg, Germany, 69126 | |
| Germany, Bayern | |
| GSK Clinical Trials Call Center | |
| Gauting, Bayern, Germany, 82131 | |
| GSK Clinical Trials Call Center | |
| Ebensfeld, Bayern, Germany, 96250 | |
| Honduras | |
| GSK Clinical Trials Call Center | |
| Tegucigalpa, Honduras | |
| Hungary | |
| GSK Clinical Trials Call Center | |
| Budapest, Hungary, 1529 | |
| GSK Clinical Trials Call Center | |
| Hungary, Hungary, 8900 | |
| Italy | |
| GSK Clinical Trials Call Center | |
| Lazio, Italy, 149 | |
| GSK Clinical Trials Call Center | |
| Roma, Italy, 184 | |
| GSK Clinical Trials Call Center | |
| Roma, Italy, 149 | |
| Italy, Liguria | |
| GSK Clinical Trials Call Center | |
| Genova, Liguria, Italy, 16132 | |
| Jamaica | |
| GSK Clinical Trials Call Center | |
| Kingston, Jamaica | |
| Korea, Republic of | |
| GSK Clinical Trials Call Center | |
| Seoul, Korea, Republic of, 120-752 | |
| GSK Clinical Trials Call Center | |
| Seoul, Korea, Republic of, 110-744 | |
| Lithuania | |
| GSK Clinical Trials Call Center | |
| Vilnius, Lithuania, LT-08660 | |
| GSK Clinical Trials Call Center | |
| Kaunas, Lithuania, LT-45434 | |
| Mexico | |
| GSK Clinical Trials Call Center | |
| Mexico City, Mexico, 14000 | |
| GSK Clinical Trials Call Center | |
| Guadalajara, Mexico, 45170 | |
| GSK Clinical Trials Call Center | |
| Chihuahua, Mexico, 31000 | |
| GSK Clinical Trials Call Center | |
| Guadalajara, Mexico, 44280 | |
| Netherlands | |
| GSK Clinical Trials Call Center | |
| Ede, Netherlands, 6716 RP | |
| GSK Clinical Trials Call Center | |
| Apeldoorn, Netherlands, 7334 DZ | |
| GSK Clinical Trials Call Center | |
| Arnheim, Netherlands, 6815 AD | |
| GSK Clinical Trials Call Center | |
| Harderwijk, Netherlands, 3844 DG | |
| GSK Clinical Trials Call Center | |
| Nieuwegein, Netherlands, 3435 CM | |
| New Zealand | |
| GSK Clinical Trials Call Center | |
| Wellington South, New Zealand, 6002 | |
| GSK Clinical Trials Call Center | |
| Hamilton, New Zealand, 2001 | |
| Norway | |
| GSK Clinical Trials Call Center | |
| Oslo, Norway, 407 | |
| Panama | |
| GSK Clinical Trials Call Center | |
| Panama, Panama | |
| Poland | |
| GSK Clinical Trials Call Center | |
| Kielce, Poland, 25-640 | |
| GSK Clinical Trials Call Center | |
| Gdansk, Poland, 80-211 | |
| Puerto Rico | |
| GSK Clinical Trials Call Center | |
| Ponce, Puerto Rico, 716 | |
| Russian Federation | |
| GSK Clinical Trials Call Center | |
| Moscow, Russian Federation, 115 478 | |
| GSK Clinical Trials Call Center | |
| Moscow, Russian Federation, 107 055 | |
| GSK Clinical Trials Call Center | |
| Moscow Region, Russian Federation, 143 423 | |
| Singapore | |
| GSK Clinical Trials Call Center | |
| Singapore, Singapore, 119074 | |
| Slovakia | |
| GSK Clinical Trials Call Center | |
| Banska Bystrica, Slovakia, 975 17 | |
| GSK Clinical Trials Call Center | |
| Nitra, Slovakia, 949 88 | |
| GSK Clinical Trials Call Center | |
| Kosice, Slovakia, 041 09 | |
| GSK Clinical Trials Call Center | |
| Bratislava, Slovakia, 825 56 | |
| South Africa, Gauteng | |
| GSK Clinical Trials Call Center | |
| Johannesburg, Gauteng, South Africa, 2193 | |
| Spain | |
| GSK Clinical Trials Call Center | |
| Lerida, Spain, 25198 | |
| GSK Clinical Trials Call Center | |
| Valencia, Spain, 46009 | |
| Taiwan | |
| GSK Clinical Trials Call Center | |
| Taipei, Taiwan, 100 | |
| GSK Clinical Trials Call Center | |
| Taipei, Taiwan, 105 | |
| United Kingdom | |
| GSK Clinical Trials Call Center | |
| Poole, United Kingdom, BH15 2JB | |
| GSK Clinical Trials Call Center | |
| Leicester, United Kingdom, LE1 5WW | |
| GSK Clinical Trials Call Center | |
| Glasgow, United Kingdom, G4 0SF | |
| GSK Clinical Trials Call Center | |
| Leeds, United Kingdom, LS16 6QB | |
| United Kingdom, Aberdeenshire | |
| GSK Clinical Trials Call Center | |
| Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD | |
| United Kingdom, Nottinghamshire | |
| GSK Clinical Trials Call Center | |
| Nottingham, Nottinghamshire, United Kingdom, NG5 1PB | |
| Study Director: | GSK Clinical Trial, MD | GlaxoSmithKline |
More Information
| Study ID Numbers: | 104864-A/389 |
| Study First Received: | August 14, 2002 |
| Last Updated: | March 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00043927 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Chemotherapy-naive Small Cell Lung Cancer SCLC Extensive disease |
ED topotecan Hycamtin oral |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs 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 |