A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer
18 Years
N/A
Both
Esophageal Cancer
Trial Information
A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer
Surgical removal has been the standard treatment for operable esophageal cancer. However,
recent studies have shown improved results when patients receive a short course of
chemotherapy and radiation therapy prior to surgery.
Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning
Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by
vein. A small portable pump will be used to administer this drug into a tube that has been
surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the
drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth
beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy
daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).
Surgery will be performed approximately 12-14 weeks after beginning this combined
treatment.
Inclusion Criteria:
- Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or
III
- No prior treatment for esophageal cancer
- Must be surgical candidate based on stage and location of disease
- Measurable or evaluable disease
- Able to be up and perform self care
- Adequate liver, renal function and bone marrow function
- Patients will have to have a central venous access device placed
- Able to give written informed consent.
- Age 18 or older
Exclusion Criteria:
- Stage IV disease
- Prior cancer treatment for advanced cancer in the last 5 years
- Pregnant or lactating women
- History of stroke, transient ischemic attacks, or acute MI within the past 6 months
or any other serious cardiovascular disease
- History of neurological disease
- Recent history of blood in the sputum or vomitus
- Non-healing wounds, ulcer or long bone fractures
- History of bleeding problems or coagulation problems
- History of abdominal fistula, gi perforation or intrabdominal abscess within 6 months
- History of uncontrolled hypertension
Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have. You can then decide if you wish to
participate.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathologic Complete Response (pCR) Rate
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
John D Hainsworth, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sarah Cannon Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
SCRI GI 91
NCT ID:
NCT00393068
Start Date:
February 2007
Completion Date:
August 2011
Related Keywords:
- Esophageal Cancer
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
| Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
| Oncology Hematology Care | Cincinnati, Ohio 45242 |
| Hematology Oncology Associates of Northern NJ | Morristown, New Jersey 07960 |
| Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee 37404 |
| Aultman Hospital | Canton, Ohio 44710 |
