39
Participants
Start Date
June 30, 2003
Primary Completion Date
May 31, 2007
carboplatin
Dosed to an AUC of 6 by the Calvert formula, intravenously over 1 hour after paclitaxel on days 1, 22, and 43.
celecoxib
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.
paclitaxel
200 mg/m2 as a 3-hour intravenous infusion on days 1, 22, and 43.
adjuvant therapy
"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."
conventional surgery
"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."
neoadjuvant therapy
"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
Collaborators (1)
Pfizer
INDUSTRY
Weill Medical College of Cornell University
OTHER