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Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00049998
First received: November 18, 2002
Last updated: March 1, 2013
Last verified: March 2013
History of Changes

November 18, 2002
March 1, 2013
October 2001
April 2004   (final data collection date for primary outcome measure)
One-year survival rate
Not Provided
Complete list of historical versions of study NCT00049998 on ClinicalTrials.gov Archive Site
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.
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Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer

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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small-Cell Lung Cancer
Drug: topotecan
Other Name: topotecan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
760
Not Provided
April 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT00049998
104864-A/387
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
March 2013

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