Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus


Last updated date
Study Location
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021, United States


Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center


By email


[email protected]

Call Now

Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Esophageal Cancer
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years


Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center


[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.


Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Esophageal CancerSunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer
  1. Columbus, Ohio
18 Years+
Esophageal CancerCelecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
  1. New York, New York
18 Years+
Esophageal CancerCombination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
  1. Norwalk, Connecticut
  2. Lewes, Delaware
  3. Newark, Delaware
  4. Washington, District of Columbia
  5. Aurora, Illinois
  6. Bloomington, Illinois
  7. Canton, Illinois
  8. Carthage, Illinois
  9. Chicago, Illinois
  10. Decatur, Illinois
  11. Eureka, Illinois
  12. Evanston, Illinois
  13. Galesburg, Illinois
  14. Galesburg, Illinois
  15. Harvey, Illinois
  16. Havana, Illinois
  17. Hopedale, Illinois
  18. Joliet, Illinois
  19. Macomb, Illinois
  20. Normal, Illinois
  21. Normal, Illinois
  22. Ottawa, Illinois
  23. Ottawa, Illinois
  24. Pekin, Illinois
  25. Peoria, Illinois
  26. Peoria, Illinois
  27. Peoria, Illinois
  28. Peoria, Illinois
  29. Peoria, Illinois
  30. Peru, Illinois
  31. Princeton, Illinois
  32. Rockford, Illinois
  33. Spring Valley, Illinois
  34. Springfield, Illinois
  35. Urbana, Illinois
  36. Urbana, Illinois
  37. Elkhart, Indiana
  38. Fort Wayne, Indiana
  39. Indianapolis, Indiana
  40. Indianapolis, Indiana
  41. Kokomo, Indiana
  42. La Porte, Indiana
  43. Michigan City, Indiana
  44. South Bend, Indiana
  45. South Bend, Indiana
  46. South Bend, Indiana
  47. South Bend, Indiana
  48. Ames, Iowa
  49. Bettendorf, Iowa
  50. Cedar Rapids, Iowa
  51. Cedar Rapids, Iowa
  52. Des Moines, Iowa
  53. Des Moines, Iowa
  54. Des Moines, Iowa
  55. Des Moines, Iowa
  56. Des Moines, Iowa
  57. Des Moines, Iowa
  58. Des Moines, Iowa
  59. Iowa City, Iowa
  60. Mason City, Iowa
  61. Ottumwa, Iowa
  62. Sioux City, Iowa
  63. Sioux City, Iowa
  64. Sioux City, Iowa
  65. West Des Moines, Iowa
  66. Anthony, Kansas
  67. Chanute, Kansas
  68. Dodge City, Kansas
  69. El Dorado, Kansas
  70. Fort Scott, Kansas
  71. Independence, Kansas
  72. Kingman, Kansas
  73. Lawrence, Kansas
  74. Liberal, Kansas
  75. Newton, Kansas
  76. Overland Park, Kansas
  77. Parsons, Kansas
  78. Pratt, Kansas
  79. Salina, Kansas
  80. Shawnee Mission, Kansas
  81. Wellington, Kansas
  82. Wichita, Kansas
  83. Wichita, Kansas
  84. Wichita, Kansas
  85. Wichita, Kansas
  86. Wichita, Kansas
  87. Winfield, Kansas
  88. Bangor, Maine
  89. Baltimore, Maryland
  90. Easton, Maryland
  91. Elkton MD, Maryland
  92. Boston, Massachusetts
  93. Boston, Massachusetts
  94. Boston, Massachusetts
  95. Burlington, Massachusetts
  96. South Weymouth, Massachusetts
  97. Springfield, Massachusetts
  98. Ann Arbor, Michigan
  99. Ann Arbor, Michigan
  100. Dearborn, Michigan
  101. Escanaba, Michigan
  102. Flint, Michigan
  103. Flint, Michigan
  104. Grosse Pointe Woods, Michigan
  105. Iron Mountain, Michigan
  106. Jackson, Michigan
  107. Kalamazoo, Michigan
  108. Kalamazoo, Michigan
  109. Kalamazoo, Michigan
  110. Lansing, Michigan
  111. Livonia, Michigan
  112. Pontiac, Michigan
  113. Port Huron, Michigan
  114. Saginaw, Michigan
  115. Saint Joseph, Michigan
  116. St. Joseph, Michigan
  117. Warren, Michigan
  118. Burnsville, Minnesota
  119. Coon Rapids, Minnesota
  120. Duluth, Minnesota
  121. Duluth, Minnesota
  122. Duluth, Minnesota
  123. Edina, Minnesota
  124. Fridley, Minnesota
  125. Hutchinson, Minnesota
  126. Lichfield, Minnesota
  127. Maplewood, Minnesota
  128. Maplewood, Minnesota
  129. Minneapolis, Minnesota
  130. Minneapolis, Minnesota
  131. Minneapolis, Minnesota
  132. Robbinsdale, Minnesota
  133. Saint Louis Park, Minnesota
  134. Saint Louis Park, Minnesota
  135. Saint Paul, Minnesota
  136. Shakopee, Minnesota
  137. St. Paul, Minnesota
  138. Waconia, Minnesota
  139. Woodbury, Minnesota
  140. Independence, Missouri
  141. Kansas City, Missouri
  142. Kansas City, Missouri
  143. Kansas City, Missouri
  144. Kansas City, Missouri
  145. Kansas City, Missouri
  146. Kansas City, Missouri
  147. Kansas City, Missouri
  148. Liberty, Missouri
  149. Saint Joseph, Missouri
  150. Saint Louis, Missouri
  151. Saint Louis, Missouri
  152. Omaha, Nebraska
  153. Omaha, Nebraska
  154. Omaha, Nebraska
  155. Omaha, Nebraska
  156. Omaha, Nebraska
  157. Las Vegas, Nevada
  158. Las Vegas, Nevada
  159. Lebanon, New Hampshire
  160. Marlton, New Jersey
  161. Newark, New Jersey
  162. Sparta, New Jersey
  163. Voorhees, New Jersey
  164. Voorhees, New Jersey
  165. Bronx, New York
  166. Buffalo, New York
  167. East Syracuse, New York
  168. Glens Falls, New York
  169. New York, New York
  170. New York, New York
  171. Chapel Hill, North Carolina
  172. Charlotte, North Carolina
  173. Goldsboro, North Carolina
  174. Hendersonville, North Carolina
  175. Kinston, North Carolina
  176. Akron, Ohio
  177. Canton, Ohio
  178. Cleveland, Ohio
  179. Columbus, Ohio
  180. Lima, Ohio
  181. Allentown, Pennsylvania
  182. Bethlehem, Pennsylvania
  183. Danville, Pennsylvania
  184. East Stroudsburg, Pennsylvania
  185. Hazleton, Pennsylvania
  186. Hershey, Pennsylvania
  187. Lewistown, Pennsylvania
  188. Philadelphia, Pennsylvania
  189. Philadelphia, Pennsylvania
  190. Philadelphia, Pennsylvania
  191. Philadelphia, Pennsylvania
  192. Philadelphia, Pennsylvania
  193. Scranton, Pennsylvania
  194. State College, Pennsylvania
  195. State College, Pennsylvania
  196. Wilkes-Barre, Pennsylvania
  197. Wilkes-Barre, Pennsylvania
  198. Williamsport, Pennsylvania
  199. Florence, South Carolina
  200. Sioux Falls, South Dakota
  201. Sioux Falls, South Dakota
  202. Sioux Falls, South Dakota
  203. Kingsport, Tennessee
  204. Temple, Texas
  205. Berlin, Vermont
  206. Burlington, Vermont
  207. Danville, Virginia
  208. Norton, Virginia
  209. Eau Claire, Wisconsin
  210. Eau Claire, Wisconsin
  211. Green Bay, Wisconsin
  212. Green Bay, Wisconsin
  213. Green Bay, Wisconsin
  214. Green Bay, Wisconsin
  215. Marinette, Wisconsin
  216. Marshfield, Wisconsin
  217. Milwaukee, Wisconsin
  218. Minocqua, Wisconsin
  219. Oconto Falls, Wisconsin
  220. Rhinelander, Wisconsin
  221. Rice Lake, Wisconsin
  222. Stevens Point, Wisconsin
  223. Sturgeon Bay, Wisconsin
  224. Wausau, Wisconsin
  225. Wausau, Wisconsin
  226. Weston, Wisconsin
  227. Wisconsin Rapids, Wisconsin
18 Years+
Esophageal CancerSutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer
  1. Ottawa, Ontario
  2. Toronto, Ontario
18 Years+
Advanced Information
Descriptive Information
Brief Title  ICMJE Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
Official Title  ICMJE A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus
Brief Summary

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.

Detailed Description



  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE
  • Drug: carboplatin
    Dosed to an AUC of 6 by the Calvert formula, intravenously over 1 hour after paclitaxel on days 1, 22, and 43.
  • Drug: 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.
    Other Name: Celebrex
  • Drug: paclitaxel
    200 mg/m2 as a 3-hour intravenous infusion on days 1, 22, and 43.
    Other Name: Taxol
  • Procedure: 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.
  • Procedure: 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.
  • Procedure: 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2009)
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE


  • Histologically confirmed esophageal cancer of 1 of the following cellular types:

    • Squamous cell
    • Adenocarcinoma
  • Potentially resectable disease
  • No distant metastases



  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified


  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • No bleeding disorder


  • Bilirubin normal
  • AST and ALT less than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN


  • Creatinine no greater than 2.0 mg/dL


  • No significant history of unstable cardiovascular disease
  • No inadequately controlled hypertension
  • No angina
  • No myocardial infarction within the past 6 months
  • No ventricular cardiac arrhythmias requiring medication
  • No congestive heart failure that would preclude study therapy


  • Pulmonary function acceptable for surgery
  • No interstitial pneumonia
  • No interstitial fibrosis


  • No history of peptic ulcer disease
  • No irritable bowel syndrome
  • No inflammatory bowel disease
  • No chronic diarrhea
  • No bowel obstruction within the past 5 years


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates
  • No hypersensitivity to paclitaxel or carboplatin
  • No other serious underlying medical condition that would preclude study therapy
  • No significant psychiatric illness that would preclude study compliance
  • No uncontrolled diabetes mellitus
  • No uncontrolled infection
  • HIV negative


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • No concurrent chronic steroid use except inhaled mometasone or fluticasone


  • Not specified


  • Not specified


  • More than 3 weeks since other prior clinical trial therapy
  • At least 72 hours since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
  • No concurrent chronic NSAID use (7 or more days of continuous therapy per month OR 3 or more days of therapy per week)
  • No other concurrent investigational agents
  • No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin or phenobarbital)
  • No other concurrent cyclo-oxygenase (COX)-2 inhibitors
  • No concurrent lithium or fluconazole
  • Concurrent low-dose aspirin (325 mg/day or less) allowed for cardiovascular prophylaxis
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00066716
Other Study ID Numbers  ICMJE CDR0000316464
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nasser Altorki, MD, Weill Cornell Medical College
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Nasser K. Altorki, MDWeill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP