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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00318903
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : January 4, 2011
Aventis Pharmaceuticals
Pharmacia and Upjohn
Information provided by:
University of Alabama at Birmingham

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. There is interest in the combination of these two active agents plus radiotherapy.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Cancer of the Esophagus Esophagus Cancer Esophageal Neoplasm Cancer of Esophagus Drug: Irinotecan (drug) Drug: Taxotere (drug) Procedure: Radiotherapy (procedure) Procedure: Esophagectomy (procedure) Phase 2

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Irinotecan and Taxotere With Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer
Study Start Date : January 2002
Actual Study Completion Date : April 2006

Arm Intervention/treatment
Experimental: Taxotere/Irinotecan
Taxotere and Irinotecan is given intravenously for 3 consecutive weeks with a one-week break before radiotherapy for 5-6 weeks. A combination of Taxotere and Irinotecan will then be administered simultaneously with the radiotherapy.
Drug: Irinotecan (drug)
50 mg/m2 of Irinotecan will be administered intravenously over 60-90 minutes following a Taxotere infusion each week for 3 weeks. After a break, Irinotecan will then be given for 3 consecutive weeks at 45 mg/m2 in conjunction with radiotherapy.
Other Name: Camptosar

Drug: Taxotere (drug)
Taxotere at 35 mg/m2 is given intravenously over 1 hour each week for three consecutive weeks. After a one-week break, patients will receive Taxotere at a 25 mg/m2 dose for the first three weeks of a 5-6 week radiotherapy regimen.
Other Name: Docetaxel

Procedure: Radiotherapy (procedure)
Radiotherapy will be given in 28 fractions over 5-6 weeks at 1.8 Gy per fraction for a total of 50.4 Gy. This will begin concurrently with chemotherapy on Day 29 of treatment.

Procedure: Esophagectomy (procedure)
After approximately 14 weeks of treatment, the patient will be evaluated for surgery. Only those who have achieved a good response will be eligible.

Primary Outcome Measures :
  1. The determination of pathologic response in patients who undergo surgical resection. [ Time Frame: Approximately 14 weeks before eligible patients have surgery ]

Secondary Outcome Measures :
  1. To assess the overall survival, time to treatment failure, and quality of life in patients who receive any therapy [ Time Frame: Approximately 4 months ]
  2. To assess the toxicities associated with this treatment and any impact on surgery. [ Time Frame: Approximately 4 months ]

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00318903

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Aventis Pharmaceuticals
Pharmacia and Upjohn
Principal Investigator: James A. Posey, M.D. University of Alabama at Birmingham

Responsible Party: James A. Posey, MD, University of Alabama at Birmingham Identifier: NCT00318903     History of Changes
Other Study ID Numbers: F001130016
UAB 0032 ( Other Identifier: institutional study protocol number )
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: December 2010

Keywords provided by University of Alabama at Birmingham:
Chemotherapy for cancer of the esophagus
Radiotherapy for cancer of the esophagus
Surgery for cancer of the esophagus
Chemotherapy, radiotherapy, surgery for esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators