Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma

This study has been terminated.
(The study was unable the accrue the required number of patients within a reasonable time.)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00570531
First received: December 10, 2007
Last updated: April 19, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Loco-regional Esophageal Cancer
Drug: Bevacizumab
Drug: Paclitaxel
Drug: Cisplatin
Drug: 5-Fluorouracil
Radiation: Radiation Therapy
Procedure: Esophagectomy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Disease Free Survival Time [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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:
  • The Number of Patients Cancer Free at the Time of Surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every three weeks for one year ] [ Designated as safety issue: Yes ]
    To assess the toxicity of this regimen.


Enrollment: 6
Study Start Date: June 2007
Study Completion Date: June 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab Drug: 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.
Other Name: Avastin
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.
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.
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.
Radiation: 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.
Procedure: Esophagectomy
Transhiatal esophagectomy performed on approximately Day #57 (6 weeks after last dose of bevacizumab.)

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570531

Sponsors and Collaborators
University of Michigan Cancer Center
Genentech, Inc.
Investigators
Principal Investigator: Susan Urba, MD University of Michigan Cancer Center
  More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00570531     History of Changes
Other Study ID Numbers: UMCC 2006.117  HUM 8625 
Study First Received: December 10, 2007
Results First Received: January 5, 2015
Last Updated: April 19, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Bevacizumab
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 21, 2016