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

This study is ongoing, but not recruiting participants.

Sponsored by: Weill Medical College of Cornell University
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00066716
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Drug: carboplatin
Drug: celecoxib
Drug: paclitaxel
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase II

MedlinePlus related topics:   Cancer    Esophageal Cancer    Esophagus Disorders   

Drug Information available for:   Carboplatin    Paclitaxel    Celecoxib    4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pathological response rate at time of surgical resection [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate 1-2 weeks prior to surgical resection [ Designated as safety issue: No ]
  • Disease-free survival 6-18 months after surgery [ Designated as safety issue: No ]
  • Overall survival 6-18 months after surgery [ Designated as safety issue: No ]
  • Toxicities and safety measured at 30 days after completion of study treatment [ Designated as safety issue: Yes ]

Study Start Date:   June 2003

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 27-39 patients will be accrued for this study within 18 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066716

Locations
United States, New York
New York Weill Cornell Cancer Center at Cornell University    
      New York, New York, United States, 10021

Sponsors and Collaborators
Weill Medical College of Cornell University

Investigators
Study Chair:     Nasser K. Altorki, MD     Weill Medical College of Cornell University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000316464, NYWCCC-0902-463
First Received:   August 6, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00066716
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the esophagus  
squamous cell carcinoma of the esophagus  
stage I esophageal cancer  
stage II esophageal cancer  
stage III esophageal cancer  

Study placed in the following topic categories:
Celecoxib
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Squamous cell carcinoma
Carboplatin
Carcinoma
Epidermoid carcinoma
Digestive System Diseases
Paclitaxel
Head and Neck Neoplasms
Carcinoma, squamous cell
Gastrointestinal Neoplasms
Esophageal Diseases
Carcinoma, Squamous Cell
Adenocarcinoma
Esophageal neoplasm

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Tubulin Modulators
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 30, 2008




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