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

April 11, 2013 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

141

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • GSK Investigational Site
      • Plovdiv, Bulgaria, 4000
        • GSK Investigational Site
      • Varna, Bulgaria, 9010
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary, 1529
        • GSK Investigational Site
      • Budapest, Hungary, 1145
        • GSK Investigational Site
      • Budapest, Hungary, 1115
        • GSK Investigational Site
      • Csorna, Hungary, 9300
        • GSK Investigational Site
      • Hungary, Hungary, 8900
        • GSK Investigational Site
      • Miskolc, Hungary, 3529
        • GSK Investigational Site
      • Törökbálint, Hungary, 2045
        • GSK Investigational Site
  • Netherlands
      • Breda, Netherlands, 4819 EV
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115 478
        • GSK Investigational Site
  • Ukraine
      • Donetsk, Ukraine
        • GSK Investigational Site
      • Lvov, Ukraine, 79031
        • GSK Investigational Site
  • United Kingdom
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G21 3UW
        • GSK Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Time to response, response rate, time to disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Study Registration Dates

First Submitted

January 11, 2006

First Submitted That Met QC Criteria

January 11, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104864/478

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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