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

Primary Purpose

Non-Small-Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
topotecan
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Cancer focused on measuring Nonsmall Cell Lung cancer, advanced, Second-line, topotecan, Hycamtin, oral, docetaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
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Outcomes

Primary Outcome Measures

One-year survival rate

Secondary Outcome Measures

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.

Full Information

First Posted
November 18, 2002
Last Updated
March 1, 2013
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00049998
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Cancer
Keywords
Nonsmall Cell Lung cancer, advanced, Second-line, topotecan, Hycamtin, oral, docetaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
760 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
topotecan
Primary Outcome Measure Information:
Title
One-year survival rate
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
GSK Investigational Site
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
GSK Investigational Site
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
GSK Investigational Site
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
GSK Investigational Site
City
St Poelten
ZIP/Postal Code
A-3100
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1220
Country
Austria
Facility Name
GSK Investigational Site
City
Braasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
GSK Investigational Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P 1P3
Country
Canada
Facility Name
GSK Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
GSK Investigational Site
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6S 1B5
Country
Canada
Facility Name
GSK Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
GSK Investigational Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
GSK Investigational Site
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
Country
China
Facility Name
GSK Investigational Site
City
Tianjin
Country
China
Facility Name
GSK Investigational Site
City
Wangfujing, Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
GSK Investigational Site
City
Ceske Budejovice
ZIP/Postal Code
370 87
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Kladno
ZIP/Postal Code
140 59
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 4
ZIP/Postal Code
14059
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Herlev
Country
Denmark
Facility Name
GSK Investigational Site
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
GSK Investigational Site
City
Caen Cedex 5
ZIP/Postal Code
14076
Country
France
Facility Name
GSK Investigational Site
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
GSK Investigational Site
City
Strasbourg Cedex
ZIP/Postal Code
67098
Country
France
Facility Name
GSK Investigational Site
City
Toulon Naval
ZIP/Postal Code
83800
Country
France
Facility Name
GSK Investigational Site
City
Vesoul Cedex
ZIP/Postal Code
70014
Country
France
Facility Name
GSK Investigational Site
City
Gauting
State/Province
Bayern
ZIP/Postal Code
82131
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
GSK Investigational Site
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93049
Country
Germany
Facility Name
GSK Investigational Site
City
Treuenbrietzen
State/Province
Brandenburg
ZIP/Postal Code
14929
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04207
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Berka
State/Province
Thueringen
ZIP/Postal Code
99437
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14109
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
GSK Investigational Site
City
Heraklion, Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
GSK Investigational Site
City
Papagos, Athens
ZIP/Postal Code
15669
Country
Greece
Facility Name
GSK Investigational Site
City
Rio, Patras
ZIP/Postal Code
265 00
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
GSK Investigational Site
City
Csorna
ZIP/Postal Code
9300
Country
Hungary
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
GSK Investigational Site
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
Facility Name
GSK Investigational Site
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
GSK Investigational Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
GSK Investigational Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00149
Country
Italy
Facility Name
GSK Investigational Site
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
GSK Investigational Site
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
Country
Italy
Facility Name
GSK Investigational Site
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06122
Country
Italy
Facility Name
GSK Investigational Site
City
Verona
State/Province
Veneto
ZIP/Postal Code
37135
Country
Italy
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1079
Country
Latvia
Facility Name
GSK Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
GSK Investigational Site
City
Vilnius
ZIP/Postal Code
LT-08660
Country
Lithuania
Facility Name
GSK Investigational Site
City
's-HERTOGENBOSCH
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
GSK Investigational Site
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Groningen
ZIP/Postal Code
9721 SW
Country
Netherlands
Facility Name
GSK Investigational Site
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
GSK Investigational Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Newtown, Wellington
ZIP/Postal Code
6002
Country
New Zealand
Facility Name
GSK Investigational Site
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1769-166
Country
Portugal
Facility Name
GSK Investigational Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115 478
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
117 837
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
129 128
Country
Russian Federation
Facility Name
GSK Investigational Site
City
N. Novgorod
ZIP/Postal Code
603 000
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Samara
ZIP/Postal Code
443066
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
GSK Investigational Site
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
GSK Investigational Site
City
Cape Town
State/Province
Western Province
Country
South Africa
Facility Name
GSK Investigational Site
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
Facility Name
GSK Investigational Site
City
Barakaldo (Vizcaya)
ZIP/Postal Code
48903
Country
Spain
Facility Name
GSK Investigational Site
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
GSK Investigational Site
City
La Laguna (Santa Cruz de Tenerife)
ZIP/Postal Code
38320
Country
Spain
Facility Name
GSK Investigational Site
City
Lerida
ZIP/Postal Code
25198
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28047
Country
Spain
Facility Name
GSK Investigational Site
City
Malaga
ZIP/Postal Code
29020
Country
Spain
Facility Name
GSK Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
GSK Investigational Site
City
Pontevedra
ZIP/Postal Code
36002
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
GSK Investigational Site
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
GSK Investigational Site
City
Tau-Yuan County
ZIP/Postal Code
333
Country
Taiwan
Facility Name
GSK Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
GSK Investigational Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
GSK Investigational Site
City
Istanbul
ZIP/Postal Code
34280
Country
Turkey
Facility Name
GSK Investigational Site
City
Izmir
ZIP/Postal Code
3510
Country
Turkey
Facility Name
GSK Investigational Site
City
Kharkov
Country
Ukraine
Facility Name
GSK Investigational Site
City
Lugansk
Country
Ukraine
Facility Name
GSK Investigational Site
City
Lvov
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
GSK Investigational Site
City
Dundee
State/Province
Forfarshire
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Nottingham
State/Province
Nottinghamshire
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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