Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer
- Determine the complete and partial response rates in patients with stage III or IV
non-small cell lung cancer treated with docetaxel and thalidomide as second-line
- Determine the toxicity of this regimen in these patients.
- Determine the response duration and survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 30-60 minutes on days 1, 8, and 15. Patients also receive
oral thalidomide once daily on days -7 to 28 for course 1 and on days 1-28 for all
subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity. Patients with stable or responding disease
after 6 courses of treatment may continue study treatment at the discretion of the
investigator. Patients discontinuing docetaxel due to toxicity may continue treatment with
thalidomide at the discretion of the investigator.
Quality of life is assessed at baseline, before each treatment course, after completion of
study treatment, and then every 3 months thereafter.
After completion of study treatment, patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Complete and partial response rates
Heidi Gillenwater, MD
University of Virginia
United States: Federal Government
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|