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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

Tracking Information
First Submitted Date  ICMJE January 11, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date April 15, 2013
Study Start Date  ICMJE November 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
Overall survival
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
Time to response, response rate, time to disease progression
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Active Symptom Control Alone Or In Combination With Oral Topotecan In Patients With Relapsed Resistant Small Cell Lung Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer, Small Cell
Intervention  ICMJE Drug: topotecan
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 11, 2006)
141
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Hungary,   Netherlands,   Russian Federation,   Ukraine,   United Kingdom
Removed Location Countries Belarus,   Canada,   Croatia,   Latvia,   Romania,   Slovakia
 
Administrative Information
NCT Number  ICMJE NCT00276276
Other Study ID Numbers  ICMJE 104864/478
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP