Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring 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)
Eligibility 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
Sites / Locations
- New York Weill Cornell Cancer Center at Cornell University