Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00049998
Last Updated: 2013-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
760 participants
INTERVENTIONAL
2001-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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topotecan
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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GSK Clinical Trials, MD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Adelaide, South Australia, Australia
GSK Investigational Site
Bedford Park, South Australia, Australia
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Melbourne, Victoria, Australia
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Ringwood East, Victoria, Australia
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Innsbruck, , Austria
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Sankt Pölten, , Austria
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Vienna, , Austria
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Braasschaat, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Liège, , Belgium
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Sydney, Nova Scotia, Canada
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Oshawa, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Xi'an, Shaanxi, China
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Beijing, , China
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Shanghai, , China
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Shanghai, , China
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Tianjin, , China
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Wangfujing, Beijing, , China
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České Budějovice, , Czechia
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Kladno, , Czechia
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Prague, , Czechia
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Herlev, , Denmark
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Odense C, , Denmark
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Helsinki, , Finland
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Turku, , Finland
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Caen, , France
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Dijon, , France
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Strasbourg, , France
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Toulon Naval, , France
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Vesoul, , France
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Gauting, Bavaria, Germany
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Munich, Bavaria, Germany
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Regensburg, Bavaria, Germany
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Treuenbrietzen, Brandenburg, Germany
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Hamburg, City state of Hamburg, Germany
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Leipzig, Saxony, Germany
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Berlin, State of Berlin, Germany
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Bad Berka, Thuringia, Germany
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Athens, , Greece
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Heraklion, Crete, , Greece
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Papagos, Athens, , Greece
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Rio, Patras, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Csorna, , Hungary
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Miskolc, , Hungary
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Ashkelon, , Israel
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Beersheba, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Rome, Lazio, Italy
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Turin, Piedmont, Italy
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Sassari, Sardinia, Italy
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Perugia, Umbria, Italy
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Verona, Veneto, Italy
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Riga, , Latvia
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Riga, , Latvia
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Kaunas, , Lithuania
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Vilnius, , Lithuania
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's-Hertogenbosch, , Netherlands
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Delft, , Netherlands
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Groningen, , Netherlands
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Heerlen, , Netherlands
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Leeuwarden, , Netherlands
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Newtown, Wellington, , New Zealand
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Quezon City, , Philippines
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Poznan, , Poland
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Warsaw, , Poland
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Lisbon, , Portugal
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Porto, , Portugal
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Singapore, , Singapore
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Pretoria, Gauteng, South Africa
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Cape Town, Western Province, South Africa
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Port Elizabeth, , South Africa
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Barakaldo (Vizcaya), , Spain
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Jaén, , Spain
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La Laguna (Santa Cruz de Tenerife), , Spain
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Lleida, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Palma de Mallorca, , Spain
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Pontevedra, , Spain
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Valencia, , Spain
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Zurich, , Switzerland
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Taipei, , Taiwan
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Tau-Yuan County, , Taiwan
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kharkiv, , Ukraine
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Luhansk, , Ukraine
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Lviv, , Ukraine
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Dundee, Forfarshire, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Leicester, Leicestershire, United Kingdom
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London, London, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
GSK Investigational Site
Guildford, Surrey, United Kingdom
Countries
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Other Identifiers
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104864-A/387
Identifier Type: -
Identifier Source: org_study_id
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