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Phase II Trial of Pre-Operative Chemoradiation Plus Bevacizumab, Followed by Surgery, and Post-Operative Adjuvant Bevacizumab for Patients With Loco-Regional Esophageal Carcinoma


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Loco-regional Esophageal Cancer

Thank you

Trial Information

Phase II Trial of Pre-Operative Chemoradiation Plus Bevacizumab, Followed by Surgery, and Post-Operative Adjuvant Bevacizumab for Patients With Loco-Regional Esophageal Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Susan Urba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2006.117

NCT ID:

NCT00570531

Start Date:

June 2007

Completion Date:

June 2015

Related Keywords:

  • Loco-regional Esophageal Cancer
  • Carcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms

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