Clinical trial NCT00049998: Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small-Cell Lung Cancer
Keywords: Nonsmall Cell Lung cancer
advanced
Second-line
topotecan
Hycamtin
oral
docetaxel
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-11-20
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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.

Primary outcomes:
measure: One-year survival rate
Secondary outcomes:
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.
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Bedford Park
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Ringwood East
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Innsbruck
country: Austria
facility: GSK Investigational Site
city: St Poelten
country: Austria
facility: GSK Investigational Site
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Braasschaat
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Edegem
country: Belgium
facility: GSK Investigational Site
city: Liege
country: Belgium
facility: GSK Investigational Site
city: Sydney
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Oshawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Thunder Bay
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Greenfield Park
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Xian
country: China
facility: GSK Investigational Site
state: Shaanxi
city: Beijing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Tianjin
country: China
facility: GSK Investigational Site
city: Wangfujing, Beijing
country: China
facility: GSK Investigational Site
city: Ceske Budejovice
country: Czech Republic
facility: GSK Investigational Site
city: Kladno
country: Czech Republic
facility: GSK Investigational Site
city: Praha 4
country: Czech Republic
facility: GSK Investigational Site
city: Herlev
country: Denmark
facility: GSK Investigational Site
city: Odense C
country: Denmark
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Caen Cedex 5
country: France
facility: GSK Investigational Site
city: Dijon Cedex
country: France
facility: GSK Investigational Site
city: Strasbourg Cedex
country: France
facility: GSK Investigational Site
city: Toulon Naval
country: France
facility: GSK Investigational Site
city: Vesoul Cedex
country: France
facility: GSK Investigational Site
city: Gauting
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Regensburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Treuenbrietzen
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Bad Berka
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Heraklion, Crete
country: Greece
facility: GSK Investigational Site
city: Papagos, Athens
country: Greece
facility: GSK Investigational Site
city: Rio, Patras
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Csorna
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Ashkelon
country: Israel
facility: GSK Investigational Site
city: Beer-Sheva
country: Israel
facility: GSK Investigational Site
city: Ramat Gan
country: Israel
facility: GSK Investigational Site
city: Tel Aviv
country: Israel
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Torino
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Sassari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Perugia
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Verona
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: 's-HERTOGENBOSCH
country: Netherlands
facility: GSK Investigational Site
city: Delft
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Heerlen
country: Netherlands
facility: GSK Investigational Site
city: Leeuwarden
country: Netherlands
facility: GSK Investigational Site
city: Newtown, Wellington
country: New Zealand
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Porto
country: Portugal
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: N. Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Samara
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Cape Town
country: South Africa
facility: GSK Investigational Site
state: Western Province
city: Port Elizabeth
country: South Africa
facility: GSK Investigational Site
city: Barakaldo (Vizcaya)
country: Spain
facility: GSK Investigational Site
city: Jaen
country: Spain
facility: GSK Investigational Site
city: La Laguna (Santa Cruz de Tenerife)
country: Spain
facility: GSK Investigational Site
city: Lerida
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Pontevedra
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Zurich
country: Switzerland
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Tau-Yuan County
country: Taiwan
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiang Mai
country: Thailand
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Izmir
country: Turkey
facility: GSK Investigational Site
city: Kharkov
country: Ukraine
facility: GSK Investigational Site
city: Lugansk
country: Ukraine
facility: GSK Investigational Site
city: Lvov
country: Ukraine
facility: GSK Investigational Site
city: Dundee
country: United Kingdom
facility: GSK Investigational Site
state: Forfarshire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Leicester
country: United Kingdom
facility: GSK Investigational Site
state: Leicestershire
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
state: Nottinghamshire
city: Guildford
country: United Kingdom
facility: GSK Investigational Site
state: Surrey
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: