Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT00008333
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine taken by mouth in treating older patients who have stage IIIB or stage IV non-small cell lung cancer.
Detailed Description:
OBJECTIVES: I. Determine the objective response rate in elderly patients with stage IIIB or IV non-small cell lung cancer treated with oral vinorelbine. II. Determine the time to progression in patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine whether there is a perceived preference for this oral administration in these patients. V. Determine the quality of life of these patients when treated with this drug. VI. Assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates in patients treated with this drug.
OUTLINE: Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed every 3 months for 5 years.
Study:
NCT00008333
Study Brief:
Protocol Section:
NCT00008333