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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Small Cell
Both
Lung Cancer, Small Cell
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
104864/478
NCT ID:
NCT00276276
Start Date:
November 2000
Completion Date:
Related Keywords:
- Lung Cancer, Small Cell
- relapsed
- lung cancer
- resistant
- small cel
- topotecan (HYCAMTIN)
- Lung Neoplasms
- Small Cell Lung Carcinoma
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