Esophageal Cancer Clinical Trial
Official title:
A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase
the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.
Celecoxib may also stop the growth of tumor cells by stopping blood flow to the tumor and/or
may block the enzymes necessary for their growth. Combining celecoxib with paclitaxel and
carboplatin before surgery may shrink the tumor so that it can be removed during surgery.
Giving celecoxib alone after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving celecoxib together with paclitaxel
and carboplatin works in treating patients who are undergoing surgery for esophageal cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
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