Clinical trial NCT00183807 (phase 2, status: terminated)
Conditions: esophageal cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: irinotecan, cisplatin, celecoxib
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Reason stopped: 
    insufficient accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have clinically documented unresectable or metastatic esophageal cancer
             and histologic confirmation of the diagnosis with tumor. To be unresectable a patient
             must have been examined by a surgeon and declared unresectable.

          -  Tissue from tumor must be available. This may be paraffin embedded tissue from
             previous biopsy/resection or if it is not available, a repeat biopsy must be
             performed.

          -  Patients must agree to have a sample 20 cc drawn in addition to routine labs with each
             cycle of chemotherapy.

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >
             20 mm with conventional techniques or as > 10 mm with spiral CT scan. If prior
             radiation therapy was administered, measurable disease must be outside the radiation
             field.

          -  Patients may have received prior adjuvant chemotherapy; this must have been completed
             at least 6 months prior to the initiation of therapy for metastatic disease.

          -  Patients must have a Zubrod performance status of 0-2.

          -  Patients must have a predicted life expectancy of at least 12 weeks.

          -  Patients must have a pre-treatment granulocyte count (i.e., segmented neutrophils +
             bands) of >1,500/mm3, a hemoglobin level of greater than or equal to9.0 gm/dl, and a
             platelet count of >100,000/mm3.

          -  Patients must have adequate renal function as documented by

             1) creatinine less than or equal to 1.5 X institutional upper limit of normal OR 2)
             creatinine clearance > 60 mL/min as calculated with

          -  Patients must have adequate hepatic function as documented by a serum bilirubin less
             than or equal to 2x the institutional upper limit of normal, regardless of whether
             patients have liver involvement secondary to tumor. Aspartate transaminase (SGOT) must
             be less than or equal to 3x institutional upper limit of normal, unless the liver is
             involved with tumor, in which case the aspartate transaminase must be less than or
             equal to 5x institutional upper limit of normal.

          -  No major surgery within 1 month of starting study drug.

        Exclusion Criteria:

          -  Patients who have received prior therapy with CPT-11 or cisplatin as adjuvant therapy
             less than 12 months prior to initiation of therapy for metastatic disease. All other
             adjuvant chemotherapy must have been completed at least 6 months prior to entry onto
             trial.

          -  Prior treatment with celebrex, that is if patients are currently using celebrex on a
             regular basis for the treatment of other disorders, i.e arthritis, etc.

          -  Patients who have received prior treatment for metastatic or unresectable disease

          -  Patients taking full-dose NSAIDs, including aspirin, regularly for any reason (e.g.,
             arthritis, history of TIA or myocardial infarction). Patients taking cardiac
             preventive dose ASA (<81mg daily) are eligible. Patients should stop taking any other
             NSAIDs 14 days prior to receiving first dose of Celecoxib.

          -  Patients may not have a history of an allergy to sulfonamide drugs.

          -  Patients may not have active peptic ulcer disease or other contraindications to
             chronic NSAID use or aspirin use.

          -  Patients may not have known lactose intolerance.

          -  Patients with any active or uncontrolled infection, including known HIV infection

          -  Patients with psychiatric disorders that would interfere with consent or follow-up

          -  Patients with a history of myocardial infarction within the previous six months or
             congestive heart failure requiring therapy Pregnant or lactating women. Men and women
             of reproductive potential may not participate unless they have agreed to use an
             effective contraceptive method.

          -  Presence of clinically apparent central nervous system metastases or carcinomatous
             meningitis

          -  Patients with a history of seizures are ineligible. Patients receiving phenytoin,
             phenobarbital, or other anti-epileptic prophylaxis are ineligible.

          -  Patients with uncontrolled diabetes mellitus, defined as random blood sugar greater
             than or equal to 200 mg/dl.

          -  Patients with any other severe concurrent disease, which in the judgment of the
             investigator, would make the patient inappropriate for entry into this study.