Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00570531
First received: December 10, 2007
Last updated: March 8, 2013
Last verified: March 2013
  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:
  • The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of whether the pre-operative treatment can eliminate all the cancer cells at the time of surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To assess the toxicity of this regimen. [ Time Frame: Every three weeks for one year ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: June 2007
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570531

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

No publications provided

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
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Bevacizumab
Cisplatin
Fluorouracil
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 23, 2014