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Trial record 1 of 1 for:    NCT00066716
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Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus

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ClinicalTrials.gov Identifier: NCT00066716
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : December 8, 2009
Sponsor:
Collaborator:
Pfizer
Information provided by:
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE August 6, 2003
First Posted Date  ICMJE August 7, 2003
Last Update Posted Date December 8, 2009
Study Start Date  ICMJE June 2003
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
Pathological response rate at time of surgical resection [ Time Frame: At completion of pathology report. ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
  • 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. ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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

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  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)
39
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

DISEASE CHARACTERISTICS:

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

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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

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

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

  • 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

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

Gastrointestinal

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • No concurrent chronic steroid use except inhaled mometasone or fluticasone

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • 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
NYWCCC-0902-463
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, MD Weill 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