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

Information source: Weill Medical College of Cornell University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Esophageal Cancer

Intervention: carboplatin (Drug); celecoxib (Drug); paclitaxel (Drug); adjuvant therapy (Procedure); conventional surgery (Procedure); neoadjuvant therapy (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: Weill Medical College of Cornell University

Official(s) and/or principal investigator(s):
Nasser K. Altorki, MD, Study Chair, Affiliation: Weill Medical College of Cornell University


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.

Clinical Details

Official title: A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pathological response rate at time of surgical resection

Secondary outcome:

Clinical response rate

Disease-free survival

Overall survival

Toxicities and safety

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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


- 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


Locations and Contacts

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

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 2003
Last updated: December 7, 2009

Page last updated: August 20, 2015

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