Last updated: 11/07/2018 00:53:11
A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer
Trial description: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Gervais R et al, Randomised phase II study of topotecan/cisplatin versus topotecan/etoposide in patients with untreated, extensive disease small cell lung cancer (SCLC), Lung Cancer, 2000, 29 (Suppl 1): 50 (Abstr 163);
Gwyther S et al, Independent review of radiology from multicentre phase II study evaluating intravenous topotecan with either cisplatin or etoposide in the first line therapy of extensive disease small cell lung cancer by validated response rate. EJC 2001, Vol 37 (Suppl 6): Abstr 215
Quoix E et al, Randomised Phase II Study of Topotecan/Cisplatin (TC) Versus Topotecan/Etoposide (TE) in Patients with Untreated, Extensive Disease, Small-Cell Lung Cancer, Proc ASCO, 2001, 20: 318a (Abstr 1268);
Quoix E et al., A randomised phase II study of the efficacy and safety of intravenous topotecan in combination with either cisplatin or etoposide in patients with untreated extensive disease small-cell lung cancer, Lung Cancer, 2005, 49(2) : 253-61
Medical condition
Lung Cancer, Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
April 1999 to July 2001
Type
Not applicable
Phase
2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2001-31-07
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
Not applicable
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