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

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Overall response rate

Principal Investigator

Howard A. Burris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2000

Completion Date:

January 2009

Related Keywords:

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



Tennessee Oncology, PLLCClarksville, Tennessee  37043