Non-Small-Cell Lung Cancer Clinical Trial
Official title:
An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer
The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).
Status | Completed |
Enrollment | 760 |
Est. completion date | |
Est. primary completion date | April 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Written informed consent - Patients with advanced non-small cell lung cancer (NSCLC). - Patients who have received one previous chemotherapy for NSCLC. - Full recovery from previous chemotherapy. - Presence of either measurable or non-measurable disease by radiologic study or physical examination. - At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient). - At least 24 hours since prior radiotherapy providing that marked bone marrow suppression is NOT expected. Patients who have received radiotherapy must have recovered from any reversible side effects (e.g. nausea and vomiting). - Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function. Exclusion Criteria: - Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment with steroids. - Active infection. - Severe medical problems other than the diagnosis of NSCLC, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk. - Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC. - Use of investigational drug within 30 days prior to the first dose of study medication. - Women who are pregnant or lactating. - Patients of child-bearing potential refusing to practice adequate birth control methods. - Patients with conditions which might alter absorption of an oral drug. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | GSK Investigational Site | Adelaide | South Australia |
Australia | GSK Investigational Site | Bedford Park | South Australia |
Australia | GSK Investigational Site | Melbourne | Victoria |
Australia | GSK Investigational Site | Ringwood East | Victoria |
Austria | GSK Investigational Site | Innsbruck | |
Austria | GSK Investigational Site | St Poelten | |
Austria | GSK Investigational Site | Vienna | |
Belgium | GSK Investigational Site | Braasschaat | |
Belgium | GSK Investigational Site | Bruxelles | |
Belgium | GSK Investigational Site | Edegem | |
Belgium | GSK Investigational Site | Liege | |
Canada | GSK Investigational Site | Greenfield Park | Quebec |
Canada | GSK Investigational Site | Montreal | Quebec |
Canada | GSK Investigational Site | Oshawa | Ontario |
Canada | GSK Investigational Site | Sainte-Foy | Quebec |
Canada | GSK Investigational Site | Sydney | Nova Scotia |
Canada | GSK Investigational Site | Thunder Bay | Ontario |
Canada | GSK Investigational Site | Toronto | Ontario |
Canada | GSK Investigational Site | Toronto | Ontario |
China | GSK Investigational Site | Beijing | |
China | GSK Investigational Site | Shanghai | |
China | GSK Investigational Site | Shanghai | |
China | GSK Investigational Site | Tianjin | |
China | GSK Investigational Site | Wangfujing, Beijing | |
China | GSK Investigational Site | Xian | Shaanxi |
Czech Republic | GSK Investigational Site | Ceske Budejovice | |
Czech Republic | GSK Investigational Site | Kladno | |
Czech Republic | GSK Investigational Site | Praha 4 | |
Denmark | GSK Investigational Site | Herlev | |
Denmark | GSK Investigational Site | Odense C | |
Finland | GSK Investigational Site | Helsinki | |
Finland | GSK Investigational Site | Turku | |
France | GSK Investigational Site | Caen Cedex 5 | |
France | GSK Investigational Site | Dijon Cedex | |
France | GSK Investigational Site | Strasbourg Cedex | |
France | GSK Investigational Site | Toulon Naval | |
France | GSK Investigational Site | Vesoul Cedex | |
Germany | GSK Investigational Site | Bad Berka | Thueringen |
Germany | GSK Investigational Site | Berlin | |
Germany | GSK Investigational Site | Gauting | Bayern |
Germany | GSK Investigational Site | Hamburg | |
Germany | GSK Investigational Site | Leipzig | Sachsen |
Germany | GSK Investigational Site | Muenchen | Bayern |
Germany | GSK Investigational Site | Regensburg | Bayern |
Germany | GSK Investigational Site | Treuenbrietzen | Brandenburg |
Greece | GSK Investigational Site | Athens | |
Greece | GSK Investigational Site | Heraklion, Crete | |
Greece | GSK Investigational Site | Papagos, Athens | |
Greece | GSK Investigational Site | Rio, Patras | |
Greece | GSK Investigational Site | Thessaloniki | |
Hungary | GSK Investigational Site | Budapest | |
Hungary | GSK Investigational Site | Csorna | |
Hungary | GSK Investigational Site | Miskolc | |
Israel | GSK Investigational Site | Ashkelon | |
Israel | GSK Investigational Site | Beer-Sheva | |
Israel | GSK Investigational Site | Ramat Gan | |
Israel | GSK Investigational Site | Tel Aviv | |
Italy | GSK Investigational Site | Perugia | Umbria |
Italy | GSK Investigational Site | Roma | Lazio |
Italy | GSK Investigational Site | Sassari | Sardegna |
Italy | GSK Investigational Site | Torino | Piemonte |
Italy | GSK Investigational Site | Verona | Veneto |
Latvia | GSK Investigational Site | Riga | |
Latvia | GSK Investigational Site | Riga | |
Lithuania | GSK Investigational Site | Kaunas | |
Lithuania | GSK Investigational Site | Vilnius | |
Netherlands | GSK Investigational Site | 's-HERTOGENBOSCH | |
Netherlands | GSK Investigational Site | Delft | |
Netherlands | GSK Investigational Site | Groningen | |
Netherlands | GSK Investigational Site | Heerlen | |
Netherlands | GSK Investigational Site | Leeuwarden | |
New Zealand | GSK Investigational Site | Newtown, Wellington | |
Philippines | GSK Investigational Site | Quezon City | |
Poland | GSK Investigational Site | Poznan | |
Poland | GSK Investigational Site | Warszawa | |
Portugal | GSK Investigational Site | Lisboa | |
Portugal | GSK Investigational Site | Porto | |
Russian Federation | GSK Investigational Site | Moscow | |
Russian Federation | GSK Investigational Site | Moscow | |
Russian Federation | GSK Investigational Site | Moscow | |
Russian Federation | GSK Investigational Site | N. Novgorod | |
Russian Federation | GSK Investigational Site | Samara | |
Russian Federation | GSK Investigational Site | St. Petersburg | |
Singapore | GSK Investigational Site | Singapore | |
South Africa | GSK Investigational Site | Cape Town | Western Province |
South Africa | GSK Investigational Site | Port Elizabeth | |
South Africa | GSK Investigational Site | Pretoria | Gauteng |
Spain | GSK Investigational Site | Barakaldo (Vizcaya) | |
Spain | GSK Investigational Site | Jaen | |
Spain | GSK Investigational Site | La Laguna (Santa Cruz de Tenerife) | |
Spain | GSK Investigational Site | Lerida | |
Spain | GSK Investigational Site | Madrid | |
Spain | GSK Investigational Site | Madrid | |
Spain | GSK Investigational Site | Madrid | |
Spain | GSK Investigational Site | Malaga | |
Spain | GSK Investigational Site | Palma de Mallorca | |
Spain | GSK Investigational Site | Pontevedra | |
Spain | GSK Investigational Site | Valencia | |
Switzerland | GSK Investigational Site | Zurich | |
Taiwan | GSK Investigational Site | Taipei | |
Taiwan | GSK Investigational Site | Tau-Yuan County | |
Thailand | GSK Investigational Site | Bangkok | |
Thailand | GSK Investigational Site | Chiang Mai | |
Turkey | GSK Investigational Site | Istanbul | |
Turkey | GSK Investigational Site | Izmir | |
Ukraine | GSK Investigational Site | Kharkov | |
Ukraine | GSK Investigational Site | Lugansk | |
Ukraine | GSK Investigational Site | Lvov | |
United Kingdom | GSK Investigational Site | Dundee | Forfarshire |
United Kingdom | GSK Investigational Site | Glasgow | Lanarkshire |
United Kingdom | GSK Investigational Site | Guildford | Surrey |
United Kingdom | GSK Investigational Site | Leicester | Leicestershire |
United Kingdom | GSK Investigational Site | London | |
United Kingdom | GSK Investigational Site | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | One-year survival rate | |||
Secondary | overall survival, time to progression, response rate, response duration, time to response, improvement in quality of life and patient well-being, and qualitative and quantitative toxicities. |
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