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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00049998




Registration number
NCT00049998
Ethics application status
Date submitted
18/11/2002
Date registered
20/11/2002
Date last updated
4/03/2013

Titles & IDs
Public title
Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
104864-A/387
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small-Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - topotecan

Treatment: Drugs: topotecan
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
One-year survival rate
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [2] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [3] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [4] 0 0
GSK Investigational Site - Ringwood East
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3128 - Ringwood East
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Austria
State/province [2] 0 0
St Poelten
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
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Belgium
State/province [4] 0 0
Braasschaat
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Edegem
Country [7] 0 0
Belgium
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Liege
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Canada
State/province [8] 0 0
Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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China
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Shaanxi
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China
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Beijing
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China
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Shanghai
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China
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Tianjin
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China
State/province [15] 0 0
Wangfujing, Beijing
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Czech Republic
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Ceske Budejovice
Country [17] 0 0
Czech Republic
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Kladno
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Czech Republic
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Praha 4
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Denmark
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Herlev
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Denmark
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Odense C
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Finland
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Helsinki
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Finland
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Turku
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France
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Caen Cedex 5
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France
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Dijon Cedex
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France
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Strasbourg Cedex
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France
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Toulon Naval
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France
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Vesoul Cedex
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Sachsen
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Germany
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Thueringen
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Germany
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Berlin
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Germany
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Hamburg
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Greece
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Athens
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Greece
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Heraklion, Crete
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Greece
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Papagos, Athens
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Greece
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Rio, Patras
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Csorna
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Hungary
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Miskolc
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Israel
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Ashkelon
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Israel
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Beer-Sheva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Lazio
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Italy
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Piemonte
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Italy
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Sardegna
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Italy
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Umbria
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Italy
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Veneto
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Latvia
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Riga
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Netherlands
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's-HERTOGENBOSCH
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Netherlands
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Delft
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Netherlands
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Groningen
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Netherlands
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Heerlen
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Netherlands
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Leeuwarden
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New Zealand
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Newtown, Wellington
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Philippines
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Quezon City
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Poland
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Poznan
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Poland
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Warszawa
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Portugal
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Lisboa
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Portugal
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Porto
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Russian Federation
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Moscow
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Russian Federation
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N. Novgorod
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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South Africa
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Gauteng
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South Africa
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Western Province
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South Africa
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Port Elizabeth
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Spain
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Barakaldo (Vizcaya)
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Spain
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Jaen
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Spain
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La Laguna (Santa Cruz de Tenerife)
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Spain
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Lerida
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Palma de Mallorca
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Spain
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Pontevedra
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Spain
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Valencia
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Switzerland
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Zurich
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Taiwan
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Taipei
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Taiwan
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Tau-Yuan County
Country [85] 0 0
Thailand
State/province [85] 0 0
Bangkok
Country [86] 0 0
Thailand
State/province [86] 0 0
Chiang Mai
Country [87] 0 0
Turkey
State/province [87] 0 0
Istanbul
Country [88] 0 0
Turkey
State/province [88] 0 0
Izmir
Country [89] 0 0
Ukraine
State/province [89] 0 0
Kharkov
Country [90] 0 0
Ukraine
State/province [90] 0 0
Lugansk
Country [91] 0 0
Ukraine
State/province [91] 0 0
Lvov
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Forfarshire
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Lanarkshire
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Leicestershire
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Nottinghamshire
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Surrey
Country [97] 0 0
United Kingdom
State/province [97] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00049998
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MD
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00049998