Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Other NYWCCC-0902-463 NCT00066716

Objectives

Primary

1. 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

1. Determine the clinical response rate of patients treated with this regimen.
2. Determine the chemotherapy-related toxicity of this regimen in these patients.
3. Determine the time to progression, disease-free survival, and overall survival of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

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



• Potentially resectable disease



• No distant metastases

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 80-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Pathological response rate at time of surgical resection

Overall response rate 1-2 weeks prior to surgical resection
Disease-free survival 6-18 months after surgery
Overall survival 6-18 months after surgery
Toxicities and safety measured at 30 days after completion of study treatment

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.

Trial Contact Information

Trial Lead Organizations

New York Weill Cornell Cancer Center at Cornell University

Nasser Altorki, MD, Protocol chair		Ph: 212-746-5156 Email: nkaltork@med.cornell.edu

Registry Information
Official Title		A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus
Trial Start Date		2003-06-30
Registered in ClinicalTrials.gov		NCT00066716
Date Submitted to PDQ		2003-06-27
Information Last Verified		2005-11-30

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