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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Dosed to an AUC of 6 by the Calvert formula, intravenously over 1 hour after paclitaxel on days 1, 22, and 43.
400 mg orally BID begins 3-7 days before the first dose of chemotherapy to the morning of surgery. Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year total, that is, 1 year from the date of surgery + 2 weeks unless tumor recurrence is documented.
200 mg/m2 as a 3-hour intravenous infusion on days 1, 22, and 43.
1. Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin. 2. Operation will be performed within 6-12 hours from the last dose of celecoxib. 3. Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection. 4. Celecoxib 400 mg orally BID will resume post-operatively 4-8 weeks if there is adequate wound healing and will be continued for 1 year.
1. Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin. 2. Operation will be performed within 6-12 hours from the last dose of celecoxib. 3. Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection.
1. Surgery will be performed 3-4 weeks after the third dose of paclitaxel and carboplatin. 2. Operation will be performed within 6-12 hours from the last dose of celecoxib. 3. Surgery will include an esophagectomy as well as a complete mediastinal and abdominal lymph node dissection.
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Pathological response rate at time of surgical resection
Time frame: At completion of pathology report.
Clinical response rate
Time frame: At the time of tumor assessment obtained prior to definitive surgery approximately 1-2 weeks prior to surgical resection.
Disease-free survival
Time frame: From start of treatment to time of recurrent disease measured postoperatively every 6 months for 18 months.
Overall survival
Time frame: 18 months after surgery
Toxicities and safety
Time frame: 30 days after completion of study treatment.
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