Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

There is a need for more effective therapy for patients following surgery for esophageal carcinoma. Docetaxel and Irinotecan, independent of each other, have demonstrated activity in this disease. There is interest in the combination of these two active agents plus radiotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborators: Aventis Pharmaceuticals; Pharmacia and Upjohn
• Treatments: Camptothecin; Docetaxel; Irinotecan

Criteria

Inclusion Criteria:

• Histological confirmation of adenocarcinoma/squamous cell carcinoma of the esophagus. Patients should be considered resection candidates, Clinical Stages II- IV (For GE junction tumors 50% of the tumor must be within the esophagus)

• Age 19 years

• 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.

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

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

• Patients must demonstrate a ECOG P.S. ≤ 1

• Minimum life expectancy of 12 weeks

• End Organ function must be adequate meeting the below criteria at baseline:

WBC 3000/mm3, ANC 1500/mm3 , Hgb 9.0 g/dL, PLT 100,000mm3 Normal serum creatinine ( 1.5 mg/dL) Total Bilirubin ULN, Transaminases (SGOT and/or SGPT) may be up to 1.5 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 1mg of Coumadin for line patency) Peripheral neuropathy must be < Grade 1

Exclusion Criteria:

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

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

• Presence of an underlying disease state associated with impairment of performance status

• New York Heart Association Class IV congestive heart failure

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

History of non-compliance with prescribed medical care.

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