Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma

University of Michigan Rogel Cancer Center

Status and phase: Terminated; Phase 2

Conditions: Loco-regional Esophageal Cancer

Treatments: Drug: Cisplatin; Radiation: Radiation Therapy; Procedure: Esophagectomy; Drug: Bevacizumab; Drug: 5-Fluorouracil; Drug: Paclitaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00570531

HUM 8625 (Other Identifier)

UMCC 2006.117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Bevacizumab

Experimental group

Treatment:

Drug: Cisplatin

Radiation: Radiation Therapy

Procedure: Esophagectomy

Drug: 5-Fluorouracil

Drug: Bevacizumab

Drug: Paclitaxel