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Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-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: NCT00049998
Recruitment Status : Completed
First Posted : November 20, 2002
Last Update Posted : March 4, 2013
Sponsor:
Information provided by:
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE November 18, 2002
First Posted Date  ICMJE November 20, 2002
Last Update Posted Date March 4, 2013
Study Start Date  ICMJE October 2001
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2006)
One-year survival rate
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2006)
overall survival, time to progression, response rate, response duration, time to response, improvement in quality of life and patient well-being, and qualitative and quantitative toxicities.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer
Brief Summary The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small-Cell Lung Cancer
Intervention  ICMJE Drug: topotecan
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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: March 8, 2006)
760
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent
  • Patients with advanced non-small cell lung cancer (NSCLC).
  • Patients who have received one previous chemotherapy for NSCLC.
  • Full recovery from previous chemotherapy.
  • Presence of either measurable or non-measurable disease by radiologic study or physical examination.
  • At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
  • At least 24 hours since prior radiotherapy providing that marked bone marrow suppression is NOT expected. Patients who have received radiotherapy must have recovered from any reversible side effects (e.g. nausea and vomiting).
  • Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion Criteria:

  • Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment with steroids.
  • Active infection.
  • Severe medical problems other than the diagnosis of NSCLC, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
  • Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
  • Use of investigational drug within 30 days prior to the first dose of study medication.
  • Women who are pregnant or lactating.
  • Patients of child-bearing potential refusing to practice adequate birth control methods.
  • Patients with conditions which might alter absorption of an oral drug.
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 Australia,   Austria,   Belgium,   Canada,   China,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Latvia,   Lithuania,   Netherlands,   New Zealand,   Philippines,   Poland,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00049998
Other Study ID Numbers  ICMJE 104864-A/387
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Study Director, GSK
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date March 2013

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