Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Country [4] 0 0
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
State/province [7] 0 0
Liege
Country [8] 0 0
Canada
State/province [8] 0 0
Nova Scotia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
China
State/province [11] 0 0
Shaanxi
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
China
State/province [13] 0 0
Shanghai
Country [14] 0 0
China
State/province [14] 0 0
Tianjin
Country [15] 0 0
China
State/province [15] 0 0
Wangfujing, Beijing
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Ceske Budejovice
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Kladno
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Praha 4
Country [19] 0 0
Denmark
State/province [19] 0 0
Herlev
Country [20] 0 0
Denmark
State/province [20] 0 0
Odense C
Country [21] 0 0
Finland
State/province [21] 0 0
Helsinki
Country [22] 0 0
Finland
State/province [22] 0 0
Turku
Country [23] 0 0
France
State/province [23] 0 0
Caen Cedex 5
Country [24] 0 0
France
State/province [24] 0 0
Dijon Cedex
Country [25] 0 0
France
State/province [25] 0 0
Strasbourg Cedex
Country [26] 0 0
France
State/province [26] 0 0
Toulon Naval
Country [27] 0 0
France
State/province [27] 0 0
Vesoul Cedex
Country [28] 0 0
Germany
State/province [28] 0 0
Bayern
Country [29] 0 0
Germany
State/province [29] 0 0
Brandenburg
Country [30] 0 0
Germany
State/province [30] 0 0
Sachsen
Country [31] 0 0
Germany
State/province [31] 0 0
Thueringen
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Hamburg
Country [34] 0 0
Greece
State/province [34] 0 0
Athens
Country [35] 0 0
Greece
State/province [35] 0 0
Heraklion, Crete
Country [36] 0 0
Greece
State/province [36] 0 0
Papagos, Athens
Country [37] 0 0
Greece
State/province [37] 0 0
Rio, Patras
Country [38] 0 0
Greece
State/province [38] 0 0
Thessaloniki
Country [39] 0 0
Hungary
State/province [39] 0 0
Budapest
Country [40] 0 0
Hungary
State/province [40] 0 0
Csorna
Country [41] 0 0
Hungary
State/province [41] 0 0
Miskolc
Country [42] 0 0
Israel
State/province [42] 0 0
Ashkelon
Country [43] 0 0
Israel
State/province [43] 0 0
Beer-Sheva
Country [44] 0 0
Israel
State/province [44] 0 0
Ramat Gan
Country [45] 0 0
Israel
State/province [45] 0 0
Tel Aviv
Country [46] 0 0
Italy
State/province [46] 0 0
Lazio
Country [47] 0 0
Italy
State/province [47] 0 0
Piemonte
Country [48] 0 0
Italy
State/province [48] 0 0
Sardegna
Country [49] 0 0
Italy
State/province [49] 0 0
Umbria
Country [50] 0 0
Italy
State/province [50] 0 0
Veneto
Country [51] 0 0
Latvia
State/province [51] 0 0
Riga
Country [52] 0 0
Lithuania
State/province [52] 0 0
Kaunas
Country [53] 0 0
Lithuania
State/province [53] 0 0
Vilnius
Country [54] 0 0
Netherlands
State/province [54] 0 0
's-HERTOGENBOSCH
Country [55] 0 0
Netherlands
State/province [55] 0 0
Delft
Country [56] 0 0
Netherlands
State/province [56] 0 0
Groningen
Country [57] 0 0
Netherlands
State/province [57] 0 0
Heerlen
Country [58] 0 0
Netherlands
State/province [58] 0 0
Leeuwarden
Country [59] 0 0
New Zealand
State/province [59] 0 0
Newtown, Wellington
Country [60] 0 0
Philippines
State/province [60] 0 0
Quezon City
Country [61] 0 0
Poland
State/province [61] 0 0
Poznan
Country [62] 0 0
Poland
State/province [62] 0 0
Warszawa
Country [63] 0 0
Portugal
State/province [63] 0 0
Lisboa
Country [64] 0 0
Portugal
State/province [64] 0 0
Porto
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Moscow
Country [66] 0 0
Russian Federation
State/province [66] 0 0
N. Novgorod
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Samara
Country [68] 0 0
Russian Federation
State/province [68] 0 0
St. Petersburg
Country [69] 0 0
Singapore
State/province [69] 0 0
Singapore
Country [70] 0 0
South Africa
State/province [70] 0 0
Gauteng
Country [71] 0 0
South Africa
State/province [71] 0 0
Western Province
Country [72] 0 0
South Africa
State/province [72] 0 0
Port Elizabeth
Country [73] 0 0
Spain
State/province [73] 0 0
Barakaldo (Vizcaya)
Country [74] 0 0
Spain
State/province [74] 0 0
Jaen
Country [75] 0 0
Spain
State/province [75] 0 0
La Laguna (Santa Cruz de Tenerife)
Country [76] 0 0
Spain
State/province [76] 0 0
Lerida
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Spain
State/province [77] 0 0
Madrid
Country [78] 0 0
Spain
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Malaga
Country [79] 0 0
Spain
State/province [79] 0 0
Palma de Mallorca
Country [80] 0 0
Spain
State/province [80] 0 0
Pontevedra
Country [81] 0 0
Spain
State/province [81] 0 0
Valencia
Country [82] 0 0
Switzerland
State/province [82] 0 0
Zurich
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taipei
Country [84] 0 0
Taiwan
State/province [84] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00049998