UAB 0032

A Phase II Study of Irinotecan and Taxotere with Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer

Principal Investigator: James Posey, M.D.

Sponsor: UAB Departmental Funds

Objectives

Primary Objective

1. To determine the pathologic response in patients who undergo surgical resection.

Secondary Objectives

1. To assess the overall survival, time to treatment failure and quality of life in patients who receive any therapy.



2. To assess the toxicities associated with this treatment and any impact on surgery.

Patient Selection Criteria

Inclusion Criteria

1. Histological confirmation of adenocarcinoma / squamous cell carcinoma of the esophagus.



2. Age > 19 years.



3. Male or female gender (not pregnant or lactating). If the subject is fertile, use of medically acceptable contraception will be required, and women with reproductive potential shall have a negative pregnancy test.



4. Patient should be able to understand and offer signed written informed consent prior to study entry.



5. No prior receipt of surgery, chemotherapy, radiotherapy, or immunotherapy.



6. Patients must demonstrate an ECOG P.S. of 0,1, or 2.



7. Minimum life expectancy of 12 weeks.



8. Peripheral neuropathy must be > Grade 1.



9. End organ function must be adequate, meeting the below criteria at baseline:
   
   
   • WBC > 3000/mm3, ANC > 1500/mm3, Hgb > 9.0g/dL, PLT > 100,000mm3
   
   
   
   • Normal serum creatinine (< 1.5 mg/dL). Total bilirubin < ULN, Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is > ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN.
   
   
   
   • PT/PTT below the upper limit of normal (patients may be on 1 mg of Coumadin for line patency).
   
   

Exclusion Criteria

1. Diagnosis of active, invasive (treated in past 5 years) concomitant malignancy except non-melanotic skin cancer.



2. Patients must be fully recovered from any reversible side effects of prior intervention.



3. Presence of underlying disease state associated with impairment of performance status.



4. New York Heart Association Class IV congestive heart failure.



5. Limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events cannot be provided.



6. History of non-compliance with prescribed medical care.



7. Patients with a history of severe hypersensitivity reaction to Taxotere® or other durgs formulated with polysorbate 80 must be excluded.

Additional Information

For further information, contact Jennifer Thornton, RN, OCN at (205) 975-6347 or page through the UAB Paging Operator at (205) 934-3411, Pager #5821.