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

Lung Cancer, Small Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276276
• Other study ID #: 104864/478
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2006
• Last updated: April 11, 2013
• Start date: November 2000

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer, Small Cell
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• topotecan

Locations

Country	Name	City	State
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Varna
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Csorna
Hungary	GSK Investigational Site	Hungary
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Törökbálint
Netherlands	GSK Investigational Site	Breda
Russian Federation	GSK Investigational Site	Moscow
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Lvov
United Kingdom	GSK Investigational Site	Chelmsford	Essex
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Netherlands,  Russian Federation,  Ukraine,  United Kingdom, 

References & Publications (1)

O'Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cuceviá 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	Time to response, response rate, time to disease progression