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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193245
• Other study ID #: SCRI LUN 47
• Secondary ID: 104864-450
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: June 24, 2010
• Start date: November 2000
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2009
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Topotecan

• Docetaxel

Locations

Country	Name	City	State
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (4)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	AstraZeneca, Aventis Pharmaceuticals, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Jones S, Thompson D, Barton J, Patton J, Shipley D, Greco FA, Spigel D, Infante J, Burris HA 3rd. A randomized phase II trial of oral topotecan versus docetaxel in the second-line treatment of non-small-cell lung cancer. Clin Lung Cancer. 2008 May;9(3):15 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate
Secondary	Time to Progression
Secondary	Overall survival
Secondary	Overall toxicity