Clinical trial NCT00066716 (phase 2, status: completed)
Conditions: esophageal cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: carboplatin, celecoxib, paclitaxel
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
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