Evaluation Of Celecoxib In Combination With Docetaxel In The Treatment Of Advanced Non-Small Cell Lung Cancer Patients Previously Treated With Platinum Based Chemotherapy
- Determine the efficacy and feasibility of celecoxib combined with docetaxel in patients
with advanced non-small cell lung cancer previously treated with platinum-based
- Determine the response rate of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and
docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive
2 additional courses after CR. Patients who achieve stable disease (SD) or a partial
response (PR) receive a minimum of 2 additional courses after SD or PR. At the discretion of
the treating physician, patients then receive maintenance therapy comprising celecoxib only.
Patients who discontinue therapy for disease progression or unacceptable toxicity are
followed for at least 6 months.
PROJECTED ACCRUAL: A total of 21-39 patients will be accrued for this study within 13-28
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of combining Celecoxib with Docetaxel
Blood levels of VEGF & PGE2
Weeks 1 , 2 and 3
Shirish M. Gadgeel, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|