Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma

NCT ID: NCT00570531

Last Updated: 2016-05-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2013-06-30

Brief Summary

The purpose of this study is to determine whether bevacizumab can improve the outcome of treatment for patients with esophageal cancer whose disease is confined to the esophagus or the closely surrounding lymph nodes.

Detailed Description

Standard treatment is pre-operative chemotherapy and radiation, followed by surgery. In this study, bevacizumab will be added to the pre-operative chemotherapy and radiation, and then bevacizumab will also be administered for a year after surgery. Bevacizumab is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) produced by Genentech, Inc. using recombinant DNA technology. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal cancer in combination with chemotherapy. Bevacizumab is experimental in the treatment of esophageal cancer and has not been approved by the FDA for the treatment of esophageal cancer. Bevacizumab is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a growth factor with a well defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory animals, bevacizumab inhibits the growth of several different types of human cancer cells, including colon cancer cells, by blocking the effects of VEGF. By blocking VEGF, your doctors hope that bevacizumab may decrease blood supply to the tumor, and therefore decrease the ability of the tumor to grow and come back after chemotherapy, radiation, and surgery.

Conditions

Loco-regional Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

Cisplatin

Intervention Type: DRUG

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.

5-Fluorouracil

Intervention Type: DRUG

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

Radiation Therapy

Intervention Type: RADIATION

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.

Esophagectomy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Esophagectomy

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

Intervention Type: PROCEDURE

Other Intervention Names

Avastin

Eligibility Criteria

Inclusion Criteria

1. No prior treatment for esophageal cancer

2. No prior radiation to the chest or upper abdominal area

3. No prior treatment with an EGFR inhibitor or an anti-angiogenic agent

4. Disease should be limited to the esophagus and regional lymph nodes -

Exclusion Criteria

1. History of stroke

2. History of heart attack

3. Inadequately controlled high blood pressure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Urba, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Other Identifiers

HUM 8625

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2006.117

Identifier Type: -

Identifier Source: org_study_id