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OpenTrials
Completed

NCT Number: NCT00276276

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

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.

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Key information

Conditions

Lung Cancer, Small Cell Bronchial Neoplasms Carcinoma, Bronchogenic Disease Attributes Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Pleven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topotecan

Drug

Primary outcomes

  1. Overall survival

Secondary outcomes

  1. Time to response, response rate, time to disease progression

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2000
First posted
Jan 13, 2006
Registry last updated
Apr 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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