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

This study has been completed.

First Received: September 12, 2005 Last Updated: January 15, 2009 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute AstraZeneca Aventis Pharmaceuticals GlaxoSmithKline
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193245

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 II

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, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized Trial of Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer

Further study details as provided by Sarah Cannon Research Institute:

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

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

Sarah Cannon Research Institute

AstraZeneca

Aventis Pharmaceuticals

GlaxoSmithKline

Investigators

Principal Investigator:

Howard A. Burris, MD

Sarah Cannon Research Institute

More Information

No publications provided

Study ID Numbers:	SCRI LUN 47, 104864-450
Study First Received:	September 12, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00193245 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Non-small Cell Lung Cancer
Topotecan
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Docetaxel

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Topotecan
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009