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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
- To determine
the pathologic response in patients who undergo surgical
resection.
Secondary
Objectives
- To assess
the overall survival, time to treatment failure and quality
of life in patients who receive any therapy.
- To assess
the toxicities associated with this treatment and any
impact on surgery.
PATIENT
SELECTION CRITERIA
Inclusion
Criteria
- Histological
confirmation of adenocarcinoma/squamous cell carcinoma
of 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 an ECOG P.S. of 0,1, or 2.
- Minimum life
expectancy of 12 weeks.
- Peripheral
neuropathy must be > Grade 1.
- 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
- 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
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 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.
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