Active Symptom Control Alone Or In Combination With Oral Topotecan In Patients With Relapsed Resistant Small Cell Lung Cancer

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00276276

Collaborator

(none)

141

Enrollment

Locations

8.3

Patients Per Site

Study Details

Study Description

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 therapy to make them feel better (active symptom control) to the length of time patients live when they are also receiving oral HYCAMTIN.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer, Small Cell	Drug: topotecan	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2000

Outcome Measures

Primary Outcome Measures

Overall survival []

Secondary Outcome Measures

Time to response, response rate, time to disease progression []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	GSK Investigational Site	Budapest		Hungary	1145
6	GSK Investigational Site	Budapest		Hungary	1529
7	GSK Investigational Site	Csorna		Hungary	9300
8	GSK Investigational Site	Hungary		Hungary	8900
9	GSK Investigational Site	Miskolc		Hungary	3529
10	GSK Investigational Site	Törökbálint		Hungary	2045
11	GSK Investigational Site	Breda		Netherlands	4819 EV
12	GSK Investigational Site	Moscow		Russian Federation	115 478
13	GSK Investigational Site	Donetsk		Ukraine
14	GSK Investigational Site	Lvov		Ukraine	79031
15	GSK Investigational Site	Chelmsford	Essex	United Kingdom	CM1 7ET
16	GSK Investigational Site	Glasgow	Lanarkshire	United Kingdom	G21 3UW
17	GSK Investigational Site	Sutton	Surrey	United Kingdom	SM2 5PT