A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus
- Determine the rate of complete pathological response and/or minimal residual
microscopic disease in patients with squamous cell or adenocarcinoma of the esophagus
treated with preoperative celecoxib, paclitaxel, and carboplatin.
- Determine the clinical response rate of patients treated with this regimen.
- Determine the chemotherapy-related toxicity of this regimen in these patients.
- Determine the time to progression, disease-free survival, and overall survival of
patients treated with this regimen.
OUTLINE: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days
1, 22, and 43. Patients also receive oral celecoxib twice daily beginning 3-7 days before
the first dose of chemotherapy and continuing until the morning of planned surgical
resection (between days 64 and 71). Approximately 28-56 days after resection, patients may
resume oral celecoxib twice daily and continue for 1 year in the absence of disease
progression or unacceptable toxicity.
Patients are followed periodically for 18 months after surgery.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 18 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathological response rate at time of surgical resection
At completion of pathology report.
Nasser K. Altorki, MD
Weill Medical College of Cornell University
United States: Institutional Review Board
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|