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

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00193245
• Lead Sponsor: SCRI Development Innovations, LLC

Brief 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.

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.

Study Timeline

• Study Start: 2000-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2005-10
• Status Verified: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2010-06-24
• Last Update Posted: 2010-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Overall response rate

Secondary Outcome Measures

Name	Time	Method
Time to Progression
Overall survival
Overall toxicity

Trial Locations

Locations (1)

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States