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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: AstraZeneca; Aventis Pharmaceuticals; GlaxoSmithKline
• Treatments: Docetaxel; Topotecan

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.