Small Cell Lung Cancer Clinical Trial
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.
| NCT number | NCT00043927 |
| Other study ID # | 104864-A/389 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | August 14, 2002 |
| Last updated | August 20, 2013 |
| Start date | April 2001 |
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.
| Status | Completed |
| Enrollment | 760 |
| Est. completion date | |
| Est. primary completion date | January 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Written informed consent (patient's written understanding of and agreement to participate in this study). - Patients with confirmed extensive small cell lung cancer (SCLC). - No prior chemotherapy within 5 years of the diagnosis of SCLC. - Presence of either measurable or non-measurable SCLC by X-ray or physical examination. - At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient). - At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting. - Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function. Exclusion Criteria: - Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids. - Any active infection. - Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk. - Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC. - Use of an investigational drug within 30 days before the first dose of study medication. - Women who are pregnant or lactating. - Patients of child-bearing potential who refuse to practice an adequate form of birth control. - Patients with clinical evidence of any stomach or intestinal (GI) condition. - Patients requiring treatment with the drug cyclosporin A. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | GSK Clinical Trials Call Center | Vienna | |
| Austria | GSK Clinical Trials Call Center | Vienna | |
| Austria | GSK Clinical Trials Call Center | Vienna | |
| Belgium | GSK Clinical Trials Call Center | Charleroi | |
| Belgium | GSK Clinical Trials Call Center | Edegem | |
| Belgium | GSK Clinical Trials Call Center | Haine-Saint- Paul | |
| Belgium | GSK Clinical Trials Call Center | Leuven | |
| Belgium | GSK Clinical Trials Call Center | Liege | |
| Belgium | GSK Clinical Trials Call Center | Luxembourg | |
| Brazil | GSK Clinical Trials Call Center | Belo Horizonte | |
| Brazil | GSK Clinical Trials Call Center | Caxias do Sul | |
| Brazil | GSK Clinical Trials Call Center | Fortaleza | |
| Brazil | GSK Clinical Trials Call Center | Porto Alegre | |
| Brazil | GSK Clinical Trials Call Center | Porto Alegre | |
| Brazil | GSK Clinical Trials Call Center | Rio de Janeiro | |
| Brazil | GSK Clinical Trials Call Center | Salvador | |
| Brazil | GSK Clinical Trials Call Center | Sao Paulo | |
| Brazil | GSK Clinical Trials Call Center | Sao Paulo | |
| Bulgaria | GSK Clinical Trials Call Center | Bourgas | |
| Bulgaria | GSK Clinical Trials Call Center | Plovdiv | |
| Bulgaria | GSK Clinical Trials Call Center | Sofia | |
| Bulgaria | GSK Clinical Trials Call Center | Sofia | |
| Bulgaria | GSK Clinical Trials Call Center | Varna | |
| Canada | GSK Clinical Trials Call Center | Calgary | Alberta |
| Canada | GSK Clinical Trials Call Center | Edmonton | Alberta |
| Canada | GSK Clinical Trials Call Center | Greenfield Park | Quebec |
| Canada | GSK Clinical Trials Call Center | Montreal | Quebec |
| Canada | GSK Clinical Trials Call Center | Montreal | Quebec |
| Canada | GSK Clinical Trials Call Center | Montreal | Quebec |
| Canada | GSK Clinical Trials Call Center | Newmarket | Ontario |
| Canada | GSK Clinical Trials Call Center | Oshawa | Ontario |
| Canada | GSK Clinical Trials Call Center | Ottawa | Ontario |
| Canada | GSK Clinical Trials Call Center | Peterborough | Ontario |
| Canada | GSK Clinical Trials Call Center | Sainte-Foy | Quebec |
| Canada | GSK Clinical Trials Call Center | Sault Sainte Marie | Ontario |
| Canada | GSK Clinical Trials Call Center | Sydney | Nova Scotia |
| Canada | GSK Clinical Trials Call Center | Thunder Bay | Ontario |
| Canada | GSK Clinical Trials Call Center | Toronto | Ontario |
| Canada | GSK Clinical Trials Call Center | Weston | Ontario |
| Canada | GSK Clinical Trials Call Center | Winnipeg | Manitoba |
| Chile | GSK Clinical Trials Call Center | Santiago | |
| China | GSK Clinical Trials Call Center | Beijing | |
| China | GSK Clinical Trials Call Center | Shanghai | |
| China | GSK Clinical Trials Call Center | Wangfujing | |
| China | GSK Clinical Trials Call Center | Xian | |
| Costa Rica | GSK Clinical Trials Call Center | San Jose | |
| Czech Republic | GSK Clinical Trials Call Center | Hradec Kralove | |
| Czech Republic | GSK Clinical Trials Call Center | Olomouc | |
| Czech Republic | GSK Clinical Trials Call Center | Plzen | |
| Czech Republic | GSK Clinical Trials Call Center | Praha | |
| Czech Republic | GSK Clinical Trials Call Center | Praha | |
| Estonia | GSK Clinical Trials Call Center | Tallinn | |
| Finland | GSK Clinical Trials Call Center | Helsinki | |
| Finland | GSK Clinical Trials Call Center | Kangasala | |
| Finland | GSK Clinical Trials Call Center | Oulu | |
| France | GSK Clinical Trials Call Center | Caen | |
| France | GSK Clinical Trials Call Center | Calais Cedex | |
| France | GSK Clinical Trials Call Center | Strasbourg | |
| France | GSK Clinical Trials Call Center | Vesoul | |
| Germany | GSK Clinical Trials Call Center | Ebensfeld | Bayern |
| Germany | GSK Clinical Trials Call Center | Gauting | Bayern |
| Germany | GSK Clinical Trials Call Center | Grosshansdorf | |
| Germany | GSK Clinical Trials Call Center | Heidelberg | Baden-Wurttemberg |
| Honduras | GSK Clinical Trials Call Center | Tegucigalpa | |
| Hungary | GSK Clinical Trials Call Center | Budapest | |
| Hungary | GSK Clinical Trials Call Center | Hungary | |
| Italy | GSK Clinical Trials Call Center | Genova | Liguria |
| Italy | GSK Clinical Trials Call Center | Lazio | |
| Italy | GSK Clinical Trials Call Center | Roma | |
| Italy | GSK Clinical Trials Call Center | Roma | |
| Jamaica | GSK Clinical Trials Call Center | Kingston | |
| Korea, Republic of | GSK Clinical Trials Call Center | Seoul | |
| Korea, Republic of | GSK Clinical Trials Call Center | Seoul | |
| Lithuania | GSK Clinical Trials Call Center | Kaunas | |
| Lithuania | GSK Clinical Trials Call Center | Vilnius | |
| Mexico | GSK Clinical Trials Call Center | Chihuahua | |
| Mexico | GSK Clinical Trials Call Center | Guadalajara | |
| Mexico | GSK Clinical Trials Call Center | Guadalajara | |
| Mexico | GSK Clinical Trials Call Center | Mexico City | |
| Netherlands | GSK Clinical Trials Call Center | Apeldoorn | |
| Netherlands | GSK Clinical Trials Call Center | Arnheim | |
| Netherlands | GSK Clinical Trials Call Center | Ede | |
| Netherlands | GSK Clinical Trials Call Center | Harderwijk | |
| Netherlands | GSK Clinical Trials Call Center | Nieuwegein | |
| New Zealand | GSK Clinical Trials Call Center | Hamilton | |
| New Zealand | GSK Clinical Trials Call Center | Wellington South | |
| Norway | GSK Clinical Trials Call Center | Oslo | |
| Panama | GSK Clinical Trials Call Center | Panama | |
| Poland | GSK Clinical Trials Call Center | Gdansk | |
| Poland | GSK Clinical Trials Call Center | Kielce | |
| Puerto Rico | GSK Clinical Trials Call Center | Ponce | |
| Russian Federation | GSK Clinical Trials Call Center | Moscow | |
| Russian Federation | GSK Clinical Trials Call Center | Moscow | |
| Russian Federation | GSK Clinical Trials Call Center | Moscow Region | |
| Singapore | GSK Clinical Trials Call Center | Singapore | |
| Slovakia | GSK Clinical Trials Call Center | Banska Bystrica | |
| Slovakia | GSK Clinical Trials Call Center | Bratislava | |
| Slovakia | GSK Clinical Trials Call Center | Kosice | |
| Slovakia | GSK Clinical Trials Call Center | Nitra | |
| South Africa | GSK Clinical Trials Call Center | Johannesburg | Gauteng |
| Spain | GSK Clinical Trials Call Center | Lerida | |
| Spain | GSK Clinical Trials Call Center | Valencia | |
| Taiwan | GSK Clinical Trials Call Center | Taipei | |
| Taiwan | GSK Clinical Trials Call Center | Taipei | |
| United Kingdom | GSK Clinical Trials Call Center | Aberdeen | Aberdeenshire |
| United Kingdom | GSK Clinical Trials Call Center | Glasgow | |
| United Kingdom | GSK Clinical Trials Call Center | Leeds | |
| United Kingdom | GSK Clinical Trials Call Center | Leicester | |
| United Kingdom | GSK Clinical Trials Call Center | Nottingham | Nottinghamshire |
| United Kingdom | GSK Clinical Trials Call Center | Poole | |
| United States | GSK Clinical Trials Call Center | Abingdon | Virginia |
| United States | GSK Clinical Trials Call Center | Albany | New York |
| United States | GSK Clinical Trials Call Center | Albuquerque | New Mexico |
| United States | GSK Clinical Trials Call Center | Atlanta | Georgia |
| United States | GSK Clinical Trials Call Center | Atlanta | Georgia |
| United States | GSK Clinical Trials Call Center | Atlanta | Georgia |
| United States | GSK Clinical Trials Call Center | Atlanta | Georgia |
| United States | GSK Clinical Trials Call Center | Augusta | Georgia |
| United States | GSK Clinical Trials Call Center | Aurora | Illinois |
| United States | GSK Clinical Trials Call Center | Bismarck | North Dakota |
| United States | GSK Clinical Trials Call Center | Chicago | Illinois |
| United States | GSK Clinical Trials Call Center | Chicago | Illinois |
| United States | GSK Clinical Trials Call Center | Chula Vista | California |
| United States | GSK Clinical Trials Call Center | Cleveland | Ohio |
| United States | GSK Clinical Trials Call Center | Colorado Springs | Colorado |
| United States | GSK Clinical Trials Call Center | Columbia | South Carolina |
| United States | GSK Clinical Trials Call Center | Columbus | Ohio |
| United States | GSK Clinical Trials Call Center | Cummings | Georgia |
| United States | GSK Clinical Trials Call Center | Decatur | Georgia |
| United States | GSK Clinical Trials Call Center | Elk Grove Village | Illinois |
| United States | GSK Clinical Trials Call Center | Evansville | Indiana |
| United States | GSK Clinical Trials Call Center | Fort Worth | Texas |
| United States | GSK Clinical Trials Call Center | Fountain Valley | California |
| United States | GSK Clinical Trials Call Center | Frederick | Maryland |
| United States | GSK Clinical Trials Call Center | Gainesville | Florida |
| United States | GSK Clinical Trials Call Center | Greenbrae | California |
| United States | GSK Clinical Trials Call Center | Hoover | Alabama |
| United States | GSK Clinical Trials Call Center | Houston | Texas |
| United States | GSK Clinical Trials Call Center | Laramie | Wyoming |
| United States | GSK Clinical Trials Call Center | Lemoyne | Pennsylvania |
| United States | GSK Clinical Trials Call Center | Limerick | Pennsylvania |
| United States | GSK Clinical Trials Call Center | Madison | Wisconsin |
| United States | GSK Clinical Trials Call Center | Memphis | Tennessee |
| United States | GSK Clinical Trials Call Center | Miami Shores | Florida |
| United States | GSK Clinical Trials Call Center | Minneapolis | Minnesota |
| United States | GSK Clinical Trials Call Center | Morgantown | West Virginia |
| United States | GSK Clinical Trials Call Center | New Orleans | Louisiana |
| United States | GSK Clinical Trials Call Center | New York | New York |
| United States | GSK Clinical Trials Call Center | New York | New York |
| United States | GSK Clinical Trials Call Center | Norfolk | Virginia |
| United States | GSK Clinical Trials Call Center | Norwich | Connecticut |
| United States | GSK Clinical Trials Call Center | Ocala | Florida |
| United States | GSK Clinical Trials Call Center | Olympia | Washington |
| United States | GSK Clinical Trials Call Center | Park Ridge | Illinois |
| United States | GSK Clinical Trials Call Center | Pensacola | Florida |
| United States | GSK Clinical Trials Call Center | Philadelphia | Pennsylvania |
| United States | GSK Clinical Trials Call Center | Pittsfield | Massachusetts |
| United States | GSK Clinical Trials Call Center | Portland | Oregon |
| United States | GSK Clinical Trials Call Center | Poway | California |
| United States | GSK Clinical Trials Call Center | Rancho Mirage | California |
| United States | GSK Clinical Trials Call Center | Reno | Nevada |
| United States | GSK Clinical Trials Call Center | Rochester | New York |
| United States | GSK Clinical Trials Call Center | Sacramento | California |
| United States | GSK Clinical Trials Call Center | San Diego | California |
| United States | GSK Clinical Trials Call Center | San Diego | California |
| United States | GSK Clinical Trials Call Center | Shreveport | Louisiana |
| United States | GSK Clinical Trials Call Center | Soquel | California |
| United States | GSK Clinical Trials Call Center | South Bend | Indiana |
| United States | GSK Clinical Trials Call Center | Spartanburg | South Carolina |
| United States | GSK Clinical Trials Call Center | St. Louis | Missouri |
| United States | GSK Clinical Trials Call Center | Tarpon Springs | Florida |
| United States | GSK Clinical Trials Call Center | Valhalla | New York |
| United States | GSK Clinical Trials Call Center | Vista | California |
| United States | GSK Clinical Trials Call Center | Voorhees | New Jersey |
| United States | GSK Clinical Trials Call Center | Washington | District of Columbia |
| United States | GSK Clinical Trials Call Center | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Czech Republic, Estonia, Finland, France, Germany, Honduras, Hungary, Italy, Jamaica, Korea, Republic of, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Puerto Rico, Russian Federation, Singapore, Slovakia, South Africa, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival | |||
| Secondary | response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients |
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