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

Primary Purpose

Lung Cancer, Small Cell

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
topotecan
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer, Small Cell focused on measuring relapsed, lung cancer, resistant, small cel, topotecan (HYCAMTIN)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Time to response, response rate, time to disease progression

Full Information

First Posted
January 11, 2006
Last Updated
April 11, 2013
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00276276
Brief Title
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

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Small Cell
Keywords
relapsed, lung cancer, resistant, small cel, topotecan (HYCAMTIN)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
topotecan
Primary Outcome Measure Information:
Title
Overall survival
Secondary Outcome Measure Information:
Title
Time to response, response rate, time to disease progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Pleven
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
GSK Investigational Site
City
Csorna
ZIP/Postal Code
9300
Country
Hungary
Facility Name
GSK Investigational Site
City
Hungary
ZIP/Postal Code
8900
Country
Hungary
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
GSK Investigational Site
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
GSK Investigational Site
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115 478
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Donetsk
Country
Ukraine
Facility Name
GSK Investigational Site
City
Lvov
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
GSK Investigational Site
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G21 3UW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17135646
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.
Results Reference
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Learn more about this trial

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

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