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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT00318903
Phase
PHASE2
Status
Completed

Conditions

  • Cancer of Esophagus
  • Cancer of the Esophagus
  • Esophageal Cancer
  • Esophageal Neoplasm
  • Esophagus Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan (drug) — 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.
  • Taxotere (drug) — 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.
  • Radiotherapy (procedure) — 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.
  • Esophagectomy (procedure) — 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.

Study Details

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.

Key Dates

Start date
Jan 31, 2002
Status verified
May 2023
Completion
Apr 30, 2006

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-

Find similar trials in Birmingham, AL

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
University of Alabama at Birmingham· Birmingham, AL

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