A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus
18 Years
N/A
Both
Esophageal Cancer
Trial Information
A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological response rate at time of surgical resection
Outcome Time Frame:
At completion of pathology report.
Safety Issue:
No
Principal Investigator
Nasser K. Altorki, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Weill Medical College of Cornell University
Authority:
United States: Institutional Review Board
Study ID:
CDR0000316464
NCT ID:
NCT00066716
Start Date:
June 2003
Completion Date:
Related Keywords:
- Esophageal Cancer
- adenocarcinoma of the esophagus
- squamous cell carcinoma of the esophagus
- stage I esophageal cancer
- stage II esophageal cancer
- stage III esophageal cancer
- stage IV esophageal cancer (lymph node metastasis only)
- Adenocarcinoma
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
