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Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
This study has been completed.
First Received: November 18, 2002   Last Updated: October 1, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00049998
  Purpose

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).


Condition Intervention Phase
Non-Small-Cell Lung Cancer
Drug: topotecan
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • One-year survival rate

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 760
Study Start Date: October 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049998

  Hide Study Locations
Locations
Australia, South Australia
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
GSK Investigational Site
Ringwood East, Victoria, Australia, 3128
Austria
GSK Investigational Site
Innsbruck, Austria, A-6020
GSK Investigational Site
Vienna, Austria, A-1220
GSK Investigational Site
St Poelten, Austria, A-3100
Belgium
GSK Investigational Site
Edegem, Belgium, 2650
GSK Investigational Site
Liege, Belgium, 4000
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Braasschaat, Belgium, 2930
Canada, Nova Scotia
GSK Investigational Site
Sydney, Nova Scotia, Canada, B1P 1P3
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
GSK Investigational Site
Thunder Bay, Ontario, Canada, P7B 6V4
GSK Investigational Site
Oshawa, Ontario, Canada, L1G 2B9
GSK Investigational Site
Toronto, Ontario, Canada, M6S 1B5
Canada, Quebec
GSK Investigational Site
Greenfield Park, Quebec, Canada, J4V 2H1
GSK Investigational Site
Sainte-Foy, Quebec, Canada, G1V 4G5
GSK Investigational Site
Montreal, Quebec, Canada, H3A 1A1
China
GSK Investigational Site
Wangfujing, Beijing, China, 100730
GSK Investigational Site
Shanghai, China
GSK Investigational Site
Tianjin, China
GSK Investigational Site
Shanghai, China, 200433
GSK Investigational Site
Beijing, China, 100036
China, Shaanxi
GSK Investigational Site
Xian, Shaanxi, China, 710061
Czech Republic
GSK Investigational Site
Ceske Budejovice, Czech Republic, 370 87
GSK Investigational Site
Praha 4, Czech Republic, 140 59
GSK Investigational Site
Kladno, Czech Republic, 140 59
Denmark
GSK Investigational Site
Odense C, Denmark, DK-5000
GSK Investigational Site
Herlev, Denmark
Finland
GSK Investigational Site
Helsinki, Finland, 00029
GSK Investigational Site
Turku, Finland, 20520
France
GSK Investigational Site
Dijon Cedex, France, 21079
GSK Investigational Site
Caen Cedex 5, France, 14076
GSK Investigational Site
Vesoul Cedex, France, 70014
GSK Investigational Site
Toulon Naval, France, 83800
GSK Investigational Site
Strasbourg Cedex, France, 67098
Germany
GSK Investigational Site
Berlin, Germany, 14109
GSK Investigational Site
Hamburg, Germany, 21075
Germany, Bayern
GSK Investigational Site
Regensburg, Bayern, Germany, 93049
GSK Investigational Site
Muenchen, Bayern, Germany, 80336
GSK Investigational Site
Gauting, Bayern, Germany, 82131
Germany, Brandenburg
GSK Investigational Site
Treuenbrietzen, Brandenburg, Germany, 14929
Germany, Sachsen
GSK Investigational Site
Leipzig, Sachsen, Germany, 04207
Germany, Thueringen
GSK Investigational Site
Bad Berka, Thueringen, Germany, 99437
Greece
GSK Investigational Site
Athens, Greece, 11526
GSK Investigational Site
Heraklion, Crete, Greece, 71110
GSK Investigational Site
Rio, Patras, Greece, 265 00
GSK Investigational Site
Papagos, Athens, Greece, 15669
GSK Investigational Site
Thessaloniki, Greece, 54007
Hungary
GSK Investigational Site
Miskolc, Hungary, 3529
GSK Investigational Site
Budapest, Hungary, 1529
GSK Investigational Site
Csorna, Hungary, 9300
Israel
GSK Investigational Site
Tel Aviv, Israel, 64239
GSK Investigational Site
Beer-Sheva, Israel, 84101
GSK Investigational Site
Ashkelon, Israel, 78306
GSK Investigational Site
Ramat Gan, Israel, 52621
Italy, Lazio
GSK Investigational Site
Roma, Lazio, Italy, 00149
Italy, Piemonte
GSK Investigational Site
Torino, Piemonte, Italy, 10126
Italy, Sardegna
GSK Investigational Site
Sassari, Sardegna, Italy, 07100
Italy, Umbria
GSK Investigational Site
Perugia, Umbria, Italy, 06122
Italy, Veneto
GSK Investigational Site
Verona, Veneto, Italy, 37135
Latvia
GSK Investigational Site
Riga, Latvia, LV 1079
GSK Investigational Site
Riga, Latvia, LV 1002
Lithuania
GSK Investigational Site
Vilnius, Lithuania, LT-08660
GSK Investigational Site
Kaunas, Lithuania, LT-50009
Netherlands
GSK Investigational Site
GRONINGEN, Netherlands, 9721 SW
GSK Investigational Site
DELFT, Netherlands, 2625 AD
GSK Investigational Site
's-HERTOGENBOSCH, Netherlands, 5211 NL
GSK Investigational Site
HEERLEN, Netherlands, 6419 PC
GSK Investigational Site
LEEUWARDEN, Netherlands, 8934 AD
New Zealand
GSK Investigational Site
Newtown, Wellington, New Zealand, 6002
Philippines
GSK Investigational Site
Quezon City, Philippines, 1100
Poland
GSK Investigational Site
Poznan, Poland, 60-569
GSK Investigational Site
Warszawa, Poland, 02-781
Portugal
GSK Investigational Site
Porto, Portugal, 4200-319
GSK Investigational Site
Lisboa, Portugal, 1769-166
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 117 837
GSK Investigational Site
Moscow, Russian Federation, 129 128
GSK Investigational Site
St. Petersburg, Russian Federation, 198255
GSK Investigational Site
Samara, Russian Federation, 443066
GSK Investigational Site
Moscow, Russian Federation, 115 478
GSK Investigational Site
N. Novgorod, Russian Federation, 603 000
Singapore
GSK Investigational Site
Singapore, Singapore, 119074
South Africa
GSK Investigational Site
Port Elizabeth, South Africa, 6001
South Africa, Gauteng
GSK Investigational Site
Pretoria, Gauteng, South Africa
South Africa, Western Province
GSK Investigational Site
Cape Town, Western Province, South Africa
GSK Investigational Site
Cape Town, Western Province, South Africa
Spain
GSK Investigational Site
Valencia, Spain, 46009
GSK Investigational Site
Lerida, Spain, 25198
GSK Investigational Site
Barakaldo (Vizcaya), Spain, 48903
GSK Investigational Site
Malaga, Spain, 29020
GSK Investigational Site
Jaen, Spain, 23007
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
La Laguna (Santa Cruz de Tenerife), Spain, 38320
GSK Investigational Site
Madrid, Spain, 28047
GSK Investigational Site
Pontevedra, Spain, 36002
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
Palma de Mallorca, Spain, 07014
Switzerland
GSK Investigational Site
Zurich, Switzerland, CH-8091
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Tau-Yuan County, Taiwan, 333
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Chiang Mai, Thailand, 50200
Turkey
GSK Investigational Site
Istanbul, Turkey, 34280
GSK Investigational Site
Izmir, Turkey, 3510
Ukraine
GSK Investigational Site
Lvov, Ukraine, 79031
GSK Investigational Site
Lugansk, Ukraine
GSK Investigational Site
Kharkov, Ukraine
United Kingdom
GSK Investigational Site
London, United Kingdom, SE1 9RT
United Kingdom, Forfarshire
GSK Investigational Site
Dundee, Forfarshire, United Kingdom, DD1 9SY
United Kingdom, Lanarkshire
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G4 0SF
United Kingdom, Leicestershire
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE1 5WW
United Kingdom, Nottinghamshire
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom
United Kingdom, Surrey
GSK Investigational Site
Guildford, Surrey, United Kingdom, GU2 7XX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 104864-A/387
Study First Received: November 18, 2002
Last Updated: October 1, 2009
ClinicalTrials.gov Identifier: NCT00049998     History of Changes
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Nonsmall Cell Lung cancer
advanced
Second-line
topotecan
Hycamtin
oral
docetaxel

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Topotecan
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009