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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00276276
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : April 15, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 141 participants
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 : November 2000





Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Time to response, response rate, time to disease progression


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276276


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

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00276276     History of Changes
Other Study ID Numbers: 104864/478
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: November 2012

Keywords provided by GlaxoSmithKline:
relapsed
lung cancer
resistant
small cel
topotecan (HYCAMTIN)

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents