Clinical trial NCT00276276: Active Symptom Control Alone Or In Combination With Oral Topotecan In Patients With Relapsed Resistant Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer, Small Cell
Keywords: relapsed
lung cancer
resistant
small cel
topotecan (HYCAMTIN)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-01-13
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Time to response, response rate, time to disease progression
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: GSK Investigational Site
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Varna
country: Bulgaria
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Csorna
country: Hungary
facility: GSK Investigational Site
city: Hungary
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Törökbálint
country: Hungary
facility: GSK Investigational Site
city: Breda
country: Netherlands
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Lvov
country: Ukraine
facility: GSK Investigational Site
city: Chelmsford
country: United Kingdom
facility: GSK Investigational Site
state: Essex
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Sutton
country: United Kingdom
facility: GSK Investigational Site
state: Surrey
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: O'Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cucevia B, Juhasz G, Thatcher N, Ross GA, Dane GC, Crofts T. Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol. 2006 Dec 1;24(34):5441-7. doi: 10.1200/JCO.2006.06.5821.