Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer

March 1, 2013 updated by: GlaxoSmithKline

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

760

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • GSK Investigational Site
      • Bedford Park, South Australia, Australia, 5042
        • GSK Investigational Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
      • Ringwood East, Victoria, Australia, 3128
        • GSK Investigational Site
  • Austria
      • Innsbruck, Austria, A-6020
        • GSK Investigational Site
      • St Poelten, Austria, A-3100
        • GSK Investigational Site
      • Vienna, Austria, A-1220
        • GSK Investigational Site
  • Belgium
      • Braasschaat, Belgium, 2930
        • GSK Investigational Site
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Edegem, Belgium, 2650
        • GSK Investigational Site
      • Liege, Belgium, 4000
        • GSK Investigational Site
  • Canada
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • GSK Investigational Site
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • GSK Investigational Site
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 2M9
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M6S 1B5
        • GSK Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H3A 1A1
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • GSK Investigational Site
  • China
      • Beijing, China, 100036
        • GSK Investigational Site
      • Shanghai, China, 200433
        • GSK Investigational Site
      • Shanghai, China
        • GSK Investigational Site
      • Tianjin, China
        • GSK Investigational Site
      • Wangfujing, Beijing, China, 100730
        • GSK Investigational Site
    • Shaanxi
      • Xian, Shaanxi, China, 710061
        • GSK Investigational Site
  • Czech Republic
      • Ceske Budejovice, Czech Republic, 370 87
        • GSK Investigational Site
      • Kladno, Czech Republic, 140 59
        • GSK Investigational Site
      • Praha 4, Czech Republic, 14059
        • GSK Investigational Site
  • Denmark
      • Herlev, Denmark
        • GSK Investigational Site
      • Odense C, Denmark, DK-5000
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • GSK Investigational Site
      • Turku, Finland, 20520
        • GSK Investigational Site
  • France
      • Caen Cedex 5, France, 14076
        • GSK Investigational Site
      • Dijon Cedex, France, 21079
        • GSK Investigational Site
      • Strasbourg Cedex, France, 67098
        • GSK Investigational Site
      • Toulon Naval, France, 83800
        • GSK Investigational Site
      • Vesoul Cedex, France, 70014
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 14109
        • GSK Investigational Site
      • Hamburg, Germany, 21075
        • GSK Investigational Site
    • Bayern
      • Gauting, Bayern, Germany, 82131
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80336
        • GSK Investigational Site
      • Regensburg, Bayern, Germany, 93049
        • GSK Investigational Site
    • Brandenburg
      • Treuenbrietzen, Brandenburg, Germany, 14929
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04207
        • GSK Investigational Site
    • Thueringen
      • Bad Berka, Thueringen, Germany, 99437
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 11526
        • GSK Investigational Site
      • Heraklion, Crete, Greece, 71110
        • GSK Investigational Site
      • Papagos, Athens, Greece, 15669
        • GSK Investigational Site
      • Rio, Patras, Greece, 265 00
        • GSK Investigational Site
      • Thessaloniki, Greece, 54007
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary, 1529
        • GSK Investigational Site
      • Csorna, Hungary, 9300
        • GSK Investigational Site
      • Miskolc, Hungary, 3529
        • GSK Investigational Site
  • Israel
      • Ashkelon, Israel, 78306
        • GSK Investigational Site
      • Beer-Sheva, Israel, 84101
        • GSK Investigational Site
      • Ramat Gan, Israel, 52621
        • GSK Investigational Site
      • Tel Aviv, Israel, 64239
        • GSK Investigational Site
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00149
        • GSK Investigational Site
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • GSK Investigational Site
    • Sardegna
      • Sassari, Sardegna, Italy, 07100
        • GSK Investigational Site
    • Umbria
      • Perugia, Umbria, Italy, 06122
        • GSK Investigational Site
    • Veneto
      • Verona, Veneto, Italy, 37135
        • GSK Investigational Site
  • Latvia
      • Riga, Latvia, LV 1002
        • GSK Investigational Site
      • Riga, Latvia, LV 1079
        • GSK Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-08660
        • GSK Investigational Site
  • Netherlands
      • 's-HERTOGENBOSCH, Netherlands, 5211 NL
        • GSK Investigational Site
      • Delft, Netherlands, 2625 AD
        • GSK Investigational Site
      • Groningen, Netherlands, 9721 SW
        • GSK Investigational Site
      • Heerlen, Netherlands, 6419 PC
        • GSK Investigational Site
      • Leeuwarden, Netherlands, 8934 AD
        • GSK Investigational Site
  • New Zealand
      • Newtown, Wellington, New Zealand, 6002
        • GSK Investigational Site
  • Philippines
      • Quezon City, Philippines, 1100
        • GSK Investigational Site
  • Poland
      • Poznan, Poland, 60-569
        • GSK Investigational Site
      • Warszawa, Poland, 02-781
        • GSK Investigational Site
  • Portugal
      • Lisboa, Portugal, 1769-166
        • GSK Investigational Site
      • Porto, Portugal, 4200-319
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115 478
        • GSK Investigational Site
      • Moscow, Russian Federation, 129 128
        • GSK Investigational Site
      • Moscow, Russian Federation, 117 837
        • GSK Investigational Site
      • N. Novgorod, Russian Federation, 603 000
        • GSK Investigational Site
      • Samara, Russian Federation, 443066
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 198255
        • GSK Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • GSK Investigational Site
  • South Africa
      • Port Elizabeth, South Africa, 6001
        • GSK Investigational Site
    • Gauteng
      • Pretoria, Gauteng, South Africa
        • GSK Investigational Site
    • Western Province
      • Cape Town, Western Province, South Africa
        • GSK Investigational Site
  • Spain
      • Barakaldo (Vizcaya), Spain, 48903
        • GSK Investigational Site
      • Jaen, Spain, 23007
        • GSK Investigational Site
      • La Laguna (Santa Cruz de Tenerife), Spain, 38320
        • GSK Investigational Site
      • Lerida, Spain, 25198
        • GSK Investigational Site
      • Madrid, Spain, 28047
        • GSK Investigational Site
      • Madrid, Spain, 28007
        • GSK Investigational Site
      • Madrid, Spain, 28040
        • GSK Investigational Site
      • Malaga, Spain, 29020
        • GSK Investigational Site
      • Palma de Mallorca, Spain, 07014
        • GSK Investigational Site
      • Pontevedra, Spain, 36002
        • GSK Investigational Site
      • Valencia, Spain, 46009
        • GSK Investigational Site
  • Switzerland
      • Zurich, Switzerland, CH-8091
        • GSK Investigational Site
  • Taiwan
      • Taipei, Taiwan, 100
        • GSK Investigational Site
      • Tau-Yuan County, Taiwan, 333
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • GSK Investigational Site
      • Chiang Mai, Thailand, 50200
        • GSK Investigational Site
  • Turkey
      • Istanbul, Turkey, 34280
        • GSK Investigational Site
      • Izmir, Turkey, 3510
        • GSK Investigational Site
  • Ukraine
      • Kharkov, Ukraine
        • GSK Investigational Site
      • Lugansk, Ukraine
        • GSK Investigational Site
      • Lvov, Ukraine, 79031
        • GSK Investigational Site
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • GSK Investigational Site
    • Forfarshire
      • Dundee, Forfarshire, United Kingdom, DD1 9SY
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G4 0SF
        • GSK Investigational Site
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • GSK Investigational Site
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom
        • GSK Investigational Site
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
One-year survival rate

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

November 18, 2002

First Submitted That Met QC Criteria

November 19, 2002

First Posted (Estimate)

November 20, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2013

Last Update Submitted That Met QC Criteria

March 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104864-A/387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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