Clinical trial NCT00570531: Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma
Official title: Phase II Trial of Pre-Operative Chemoradiation Plus Bevacizumab, Followed by Surgery, and Post-Operative Adjuvant Bevacizumab for Patients With Loco-Regional Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Loco-regional Esophageal Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-12-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disease Free Survival Time
timeFrame: 5 years
Secondary outcomes:
measure: The Number of Patients Cancer Free at the Time of Surgery
timeFrame: 1 year
measure: The Proportion of Toxicities Experienced by Participants
timeFrame: Every three weeks for one year
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Susan Urba, MD
role: PRINCIPAL_INVESTIGATOR
References: