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

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

January 31, 2002

Study Completion Date

April 30, 2006

Conditions
Esophageal CancerCancer of the EsophagusEsophagus CancerEsophageal NeoplasmCancer of Esophagus
Interventions
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.

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.

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.

Trial Locations (1)

35294

University of Alabama at Birmingham, Birmingham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aventis Pharmaceuticals

INDUSTRY

collaborator

Pharmacia and Upjohn

INDUSTRY

lead

University of Alabama at Birmingham

OTHER