Status:
COMPLETED
Active Symptom Control Alone Or In Combination With Oral Topotecan In Patients With Relapsed Resistant Small Cell Lung Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lung Cancer, Small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 thera...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00276276
Start Date
November 1 2000
Last Update
April 15 2013
Active Locations (17)
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1
GSK Investigational Site
Pleven, Bulgaria
2
GSK Investigational Site
Plovdiv, Bulgaria, 4000
3
GSK Investigational Site
Varna, Bulgaria, 9010
4
GSK Investigational Site
Budapest, Hungary, 1115