Last updated: 11/07/2018 00:55:50
Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: topotecan
Enrollment:
760
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Ramlau et al., JCO:24 (18), 2800-2807, 2006
Medical condition
Non-Small-Cell Lung Cancer
Product
topotecan
Collaborators
Not applicable
Study date(s)
October 2001 to April 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
no
- Written informed consent
- Patients with advanced non-small cell lung cancer (NSCLC).
- Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment with steroids.
- Active infection.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G4 0SF
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Treuenbrietzen, Brandenburg, Germany, 14929
Status
Study Complete
Location
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE1 5WW
Status
Study Complete
Location
GSK Investigational Site
La Laguna (Santa Cruz de Tenerife), Spain, 38320
Status
Study Complete
Location
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom
Status
Study Complete
Location
GSK Investigational Site
Guildford, Surrey, United Kingdom, GU2 7XX
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Quebec, Canada, J4V 2H1
Status
Study Complete
Location
GSK Investigational Site
's-HERTOGENBOSCH, Netherlands, 5211 NL
Status
Study Complete
Location
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
Status
Study Complete
Location
GSK Investigational Site
London, London, United Kingdom, SE1 9RT
Status
Study Complete
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ceske Budejovice, Czech Republic, 370 87
Status
Study Complete
Location
GSK Investigational Site
Dundee, Forfarshire, United Kingdom, DD1 9SY
Status
Study Complete
Location
GSK Investigational Site
Ringwood East, Victoria, Australia, 3128
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newtown, Wellington, New Zealand, 6002
Status
Will Be Recruiting
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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