Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

October 31, 2010

Study Completion Date

June 30, 2013

Conditions
Loco-regional Esophageal Cancer
Interventions
DRUG

Bevacizumab

Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days # 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.

DRUG

Paclitaxel

Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m2 will be administered as a 1-hour intravenous infusion on days #2, 9, 16, 23, and 30. It will be given before cisplatin administration.

DRUG

Cisplatin

Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m2 over 1 hour on days #2, 9, 16, 23, and 30. It will be given after paclitaxel.

DRUG

5-Fluorouracil

Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.

RADIATION

Radiation Therapy

Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays. CT scans, the barium swallow, the endoscopy and endoscopic ultrasound reports and PET scans should be used for tumor definition. Post-Operative Radiotherapy: In the event that gross residual disease is left behind at the time of surgery or the patient is found to have a microscopic positive deep or gastric margin following surgery, additional treatment with radiation therapy will be considered.

PROCEDURE

Esophagectomy

Transhiatal esophagectomy performed on approximately Day #57 (6 weeks after last dose of bevacizumab.)

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

University of Michigan Rogel Cancer Center

OTHER

NCT00570531 - Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma | Biotech Hunter | Biotech Hunter