Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma

Phase 2

Terminated

• Conditions: Loco-regional Esophageal Cancer
• Interventions: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: 5-Fluorouracil; Radiation: Radiation Therapy; Procedure: Esophagectomy

• Registration Number: NCT00570531
• Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Primary Completion: 2010-10
• Study Completion: 2013-06
• Results First Submitted: 2015-01-05
• Results First Submitted QC: 2015-01-05
• Results First Posted: 2015-01-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Radiation Therapy	-
Bevacizumab	Esophagectomy	-
Bevacizumab	Paclitaxel	-
Bevacizumab	Bevacizumab	-
Bevacizumab	Cisplatin	-
Bevacizumab	5-Fluorouracil	-

Primary Outcome Measures

Name	Time	Method
Disease Free Survival Time	5 years	The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.

Secondary Outcome Measures

Name	Time	Method
The Number of Patients Cancer Free at the Time of Surgery	1 year	Determination of whether the pre-operative treatment can eliminate all the cancer cells at the time of surgery.
The Proportion of Toxicities Experienced by Participants	Every three weeks for one year	To assess the toxicity of this regimen.