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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049998
• Other study ID #: 104864-A/387
• Status: Completed
• Phase: Phase 3
• First received: November 18, 2002
• Last updated: March 1, 2013
• Start date: October 2001

Study information

• Verified date: March 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 760
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• topotecan

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

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, 

Outcome

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.