Last updated: 11/03/2018 01:13:40
Active Symptom Control Alone Or In Combination With Oral Topotecan In Patients With Relapsed Resistant 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 Comparator Study of Active Symptom Control alone or in Combination with Oral Topotecan in Patients with Relapsed Resistant SCLC
Trial description: The purpose of this study is to find out if giving oral HYCAMTIN to patients with relapsed small cell lung cancer benefits them. The study will compare how long patients live when they are given therapy to make them feel better (active symptom control) to the length of time patients live when they are also receiving oral HYCAMTIN.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: topotecan
Enrollment:
141
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
O’Brien ME, J Clin Oncol. 24(34):5441-7, 2006 Dec 1.
Medical condition
Lung Cancer, Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
November 2000 to September 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Received one prior chemotherapy regimen only.
- Documented partial or complete response to first-line therapy.
- Pregnant or lactating.
- Received more than one prior regimen of chemotherapy.
Inclusion and exclusion criteria
Inclusion criteria:
- Received one prior chemotherapy regimen only.
- Documented partial or complete response to first-line therapy.
- Documented relapse of limited or extensive SCLC at least 45 days after the cessation of first-line chemotherapy.
- Not considered suitable for further intravenous chemotherapy.
- Considered to have adequate bone marrow reserve.
- Performance Status of 0, 1 or 2.
Exclusion criteria:
- Pregnant or lactating.
- Received more than one prior regimen of chemotherapy.
- Uncontrolled vomiting.
- Brain metastases.
- Active uncontrolled infection.
- Received previous treatment with HYCAMTIN.
- Received an investigational product within 30 days.
Trial location(s)
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G21 3UW
Status
Study Complete
Location
GSK Investigational Site
Chelmsford, Essex, United Kingdom, CM1 7ET
Status
Study Complete
Location
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Status
Study Complete
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
2004-07-09
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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