A Study of Irinotecan, Cisplatin and Celebrex in Patients With Metastatic or Unresectable Esophageal Cancer

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.