Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Aventis Pharmaceuticals
GlaxoSmithKline
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193245
First received: September 12, 2005
Last updated: June 24, 2010
Last verified: January 2009
  Purpose

In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with intravenous docetaxel in the second-line treatment of patients with non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: Topotecan
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall response rate

Secondary Outcome Measures:
  • Time to Progression
  • Overall survival
  • Overall toxicity

Estimated Enrollment: 80
Study Start Date: November 2000
Study Completion Date: January 2009
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

  • Topotecan
  • Docetaxel

For ever 2 patients treated, 1 will receive treatment A (Topotecan) and 1 will receive treatment B (Docetaxel). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

  Eligibility

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

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Relapsed or Progressive Disease
  • Stage IIIB (not candidate for combined modality) or IV
  • No more than one prior chemotherapy regimen
  • Able to perform activities of daily living without assistance
  • Measurable disease outside of radiation port
  • Adequate bone marrow, liver and kidney function
  • Must understand study and sign informed consent prior to enrollment

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Prior treatment with Topotecan or Docetaxel
  • Uncontrolled brain metastases
  • Moderate peripheral neuropathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193245

Locations
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
AstraZeneca
Aventis Pharmaceuticals
GlaxoSmithKline
Investigators
Principal Investigator: Howard A. Burris, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00193245     History of Changes
Other Study ID Numbers: SCRI LUN 47, 104864-450
Study First Received: September 12, 2005
Last Updated: June 24, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Topotecan
Docetaxel
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 26, 2014