ClinicalTrials.gg
CompletedNCT00049998Updated Mar 4, 2013

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

A Phase 3 interventional study of topotecan in Non-Small-Cell Lung Cancer, sponsored by GlaxoSmithKline. Completed at 114 sites in 31 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-04.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
760
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Non-Small-Cell Lung Cancer

Keywords

  • Nonsmall Cell Lung cancer
  • advanced
  • Second-line
  • topotecan
  • Hycamtin
  • oral
  • docetaxel
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 760 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
760 participants

Interventions

06

What researchers measure

Primary outcomes

  1. One-year survival rate

Secondary outcomes

  1. 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.

07

Study locations

114 sites
  • GSK Investigational Site
    Adelaide, South Australia 5000, Australia
  • GSK Investigational Site
    Bedford Park, South Australia 5042, Australia
  • GSK Investigational Site
    Melbourne, Victoria 3004, Australia
  • GSK Investigational Site
    Ringwood East, Victoria 3128, Australia
  • GSK Investigational Site
    Innsbruck, A-6020, Austria
  • GSK Investigational Site
    Sankt Pölten, A-3100, Austria
  • GSK Investigational Site
    Vienna, A-1220, Austria
  • GSK Investigational Site
    Braasschaat, 2930, Belgium
  • GSK Investigational Site
    Brussels, 1200, Belgium
  • GSK Investigational Site
    Edegem, 2650, Belgium
  • GSK Investigational Site
    Liège, 4000, Belgium
  • GSK Investigational Site
    Sydney, Nova Scotia B1P 1P3, Canada
  • GSK Investigational Site
    Oshawa, Ontario L1G 2B9, Canada
  • GSK Investigational Site
    Thunder Bay, Ontario P7B 6V4, Canada
  • GSK Investigational Site
    Toronto, Ontario M5G 2M9, Canada
  • GSK Investigational Site
    Toronto, Ontario M6S 1B5, Canada
  • GSK Investigational Site
    Greenfield Park, Quebec J4V 2H1, Canada
  • GSK Investigational Site
    Montreal, Quebec H3A 1A1, Canada
  • GSK Investigational Site
    Sainte-Foy, Quebec G1V 4G5, Canada
  • GSK Investigational Site
    Xi'an, Shaanxi 710061, China
  • GSK Investigational Site
    Beijing, 100036, China
  • GSK Investigational Site
    Shanghai, 200433, China
  • GSK Investigational Site
    Shanghai, China
  • GSK Investigational Site
    Tianjin, China
  • GSK Investigational Site
    Wangfujing, Beijing, 100730, China
  • GSK Investigational Site
    České Budějovice, 370 87, Czechia
  • GSK Investigational Site
    Kladno, 140 59, Czechia
  • GSK Investigational Site
    Prague, 14059, Czechia
  • GSK Investigational Site
    Herlev, Denmark
  • GSK Investigational Site
    Odense C, DK-5000, Denmark
  • GSK Investigational Site
    Helsinki, 00029, Finland
  • GSK Investigational Site
    Turku, 20520, Finland
  • GSK Investigational Site
    Caen, 14076, France
  • GSK Investigational Site
    Dijon, 21079, France
  • GSK Investigational Site
    Strasbourg, 67098, France
  • GSK Investigational Site
    Toulon Naval, 83800, France
  • GSK Investigational Site
    Vesoul, 70014, France
  • GSK Investigational Site
    Gauting, Bavaria 82131, Germany
  • GSK Investigational Site
    Munich, Bavaria 80336, Germany
  • GSK Investigational Site
    Regensburg, Bavaria 93049, Germany
  • GSK Investigational Site
    Treuenbrietzen, Brandenburg 14929, Germany
  • GSK Investigational Site
    Hamburg, Free and Hanseatic City of Hamburg 21075, Germany
  • GSK Investigational Site
    Leipzig, Saxony 04207, Germany
  • GSK Investigational Site
    Berlin, State of Berlin 14109, Germany
  • GSK Investigational Site
    Bad Berka, Thuringia 99437, Germany
  • GSK Investigational Site
    Athens, 11526, Greece
  • GSK Investigational Site
    Heraklion, Crete, 71110, Greece
  • GSK Investigational Site
    Papagos, Athens, 15669, Greece
  • GSK Investigational Site
    Rio, Patras, 265 00, Greece
  • GSK Investigational Site
    Thessaloniki, 54007, Greece
  • GSK Investigational Site
    Budapest, 1529, Hungary
  • GSK Investigational Site
    Csorna, 9300, Hungary
  • GSK Investigational Site
    Miskolc, 3529, Hungary
  • GSK Investigational Site
    Ashkelon, 78306, Israel
  • GSK Investigational Site
    Beersheba, 84101, Israel
  • GSK Investigational Site
    Ramat Gan, 52621, Israel
  • GSK Investigational Site
    Tel Aviv, 64239, Israel
  • GSK Investigational Site
    Rome, Lazio 00149, Italy
  • GSK Investigational Site
    Turin, Piedmont 10126, Italy
  • GSK Investigational Site
    Sassari, Sardinia 07100, Italy
  • GSK Investigational Site
    Perugia, Umbria 06122, Italy
  • GSK Investigational Site
    Verona, Veneto 37135, Italy
  • GSK Investigational Site
    Riga, LV 1002, Latvia
  • GSK Investigational Site
    Riga, LV 1079, Latvia
  • GSK Investigational Site
    Kaunas, LT-50009, Lithuania
  • GSK Investigational Site
    Vilnius, LT-08660, Lithuania
  • GSK Investigational Site
    's-Hertogenbosch, 5211 NL, Netherlands
  • GSK Investigational Site
    Delft, 2625 AD, Netherlands
  • GSK Investigational Site
    Groningen, 9721 SW, Netherlands
  • GSK Investigational Site
    Heerlen, 6419 PC, Netherlands
  • GSK Investigational Site
    Leeuwarden, 8934 AD, Netherlands
  • GSK Investigational Site
    Newtown, Wellington, 6002, New Zealand
  • GSK Investigational Site
    Quezon City, 1100, Philippines
  • GSK Investigational Site
    Poznan, 60-569, Poland
  • GSK Investigational Site
    Warsaw, 02-781, Poland
  • GSK Investigational Site
    Lisbon, 1769-166, Portugal
  • GSK Investigational Site
    Porto, 4200-319, Portugal
  • GSK Investigational Site
    Moscow, 115 478, Russia
  • GSK Investigational Site
    Moscow, 117 837, Russia
  • GSK Investigational Site
    Moscow, 129 128, Russia
  • GSK Investigational Site
    Nizhny Novgorod, 603 000, Russia
  • GSK Investigational Site
    Saint Petersburg, 198255, Russia
  • GSK Investigational Site
    Samara, 443066, Russia
  • GSK Investigational Site
    Singapore, 119074, Singapore
  • GSK Investigational Site
    Pretoria, Gauteng, South Africa
  • GSK Investigational Site
    Cape Town, Western Province, South Africa
  • GSK Investigational Site
    Port Elizabeth, 6001, South Africa
  • GSK Investigational Site
    Barakaldo (Vizcaya), 48903, Spain
  • GSK Investigational Site
    Jaén, 23007, Spain
  • GSK Investigational Site
    La Laguna (Santa Cruz de Tenerife), 38320, Spain
  • GSK Investigational Site
    Lleida, 25198, Spain
  • GSK Investigational Site
    Madrid, 28007, Spain
  • GSK Investigational Site
    Madrid, 28040, Spain
  • GSK Investigational Site
    Madrid, 28047, Spain
  • GSK Investigational Site
    Málaga, 29020, Spain
  • GSK Investigational Site
    Palma de Mallorca, 07014, Spain
  • GSK Investigational Site
    Pontevedra, 36002, Spain
  • GSK Investigational Site
    Valencia, 46009, Spain
  • GSK Investigational Site
    Zurich, CH-8091, Switzerland
  • GSK Investigational Site
    Taipei, 100, Taiwan

Showing the first 100 of 114 sites across 31 countries.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00049998
Lead sponsor
GlaxoSmithKline
First posted
Nov 20, 2002
Start date
Oct 2001
Primary completion
Apr 2004
Last update
Mar 4, 2013

Study contacts

GSK Clinical Trials, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Topotecan

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