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

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00049998
  Purpose

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 Intervention Phase
Non-Small-Cell Lung Cancer
Drug: topotecan
Phase III

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Docetaxel    Topotecan hydrochloride    Topotecan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • One-year survival rate

Secondary Outcome Measures:
  • 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.

Estimated Enrollment:   760
Study Start Date:   October 2001

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049998

Show 115 study locations  Show 115 Study Locations

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD     GlaxoSmithKline    
  More Information


Responsible Party:   GSK ( Study Director )
Study ID Numbers:   104864-A/387
First Received:   November 18, 2002
Last Updated:   November 19, 2008
ClinicalTrials.gov Identifier:   NCT00049998
Health Authority:   United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Nonsmall Cell Lung cancer  
advanced  
Second-line  
topotecan  
Hycamtin
oral
docetaxel

Study placed in the following topic categories:
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Topotecan
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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