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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. Identifier: NCT00049998
Recruitment Status : Completed
First Posted : November 20, 2002
Last Update Posted : March 4, 2013
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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).

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: topotecan Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer
Study Start Date : October 2001
Actual Primary Completion Date : April 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. One-year survival rate

Secondary Outcome Measures :
  1. 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.

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

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.

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 identifier (NCT number): NCT00049998

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Sponsors and Collaborators
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
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Responsible Party: Study Director, GSK Identifier: NCT00049998    
Other Study ID Numbers: 104864-A/387
First Posted: November 20, 2002    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013
Keywords provided by GlaxoSmithKline:
Nonsmall Cell Lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents