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

NCT00066716 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2009-12-08

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer

Interventions

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.

DRUG

paclitaxel

200 mg/m2 as a 3-hour intravenous infusion on days 1, 22, and 43.

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Nasser K. Altorki, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2007-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00066716 on ClinicalTrials.gov