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

Phase 2
19 Years
Not Enrolling
Esophageal Cancer, Cancer of the Esophagus, Esophagus Cancer, Esophageal Neoplasm, Cancer of Esophagus

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Trial Information

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

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 management of micrometastatic disease and radiosensitization. A
longstanding regimen, 5-FU and Cisplatin, have failed to produce a substantial survival
benefit, but the approach has resulted in pathologic complete responses prior to surgical
eradication of the diseased organ. This raises questions of organ preservation in some
patients. Docetaxel and Irinotecan have both demonstrated independent activity in this
disease and are radiosensitizers. In this study, Docetaxel and Irinotecan will be given
together weekly for 3 consecutive weeks in an attempt to decrease the recurrence of systemic
disease, and this will be followed by giving each agent independently with radiation therapy
to decrease the local relapse rate and independently measure the toxicity of each with
radiation. Following completion of chemoradiotherapy, the patients will undergo resection
and be evaluated for the pathologic response rate.

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

- Presence of an underlying disease state associated with impairment of performance

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The determination of pathologic response in patients who undergo surgical resection.

Outcome Time Frame:

Approximately 14 weeks before eligible patients have surgery

Safety Issue:


Principal Investigator

James A. Posey, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Institutional Review Board

Study ID:




Start Date:

January 2002

Completion Date:

April 2006

Related Keywords:

  • Esophageal Cancer
  • Cancer of the Esophagus
  • Esophagus Cancer
  • Esophageal Neoplasm
  • Cancer of Esophagus
  • Chemotherapy for cancer of the esophagus
  • Radiotherapy for cancer of the esophagus
  • Surgery for cancer of the esophagus
  • Chemotherapy, radiotherapy, surgery for esophageal cancer
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms



University of Alabama at Birmingham Birmingham, Alabama  35294-3300