Status:
COMPLETED
Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Aventis Pharmaceuticals
Pharmacia and Upjohn
Conditions:
Esophageal Cancer
Cancer of the Esophagus
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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. The...
Detailed Description
The high rate of local and distant failure following surgery for esophageal carcinoma necessitates a more effective therapy for these patients. The merit of neoadjuvant chemotherapy is early managemen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00318903
Start Date
January 1 2002
End Date
April 1 2006
Last Update
May 25 2023
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294