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A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

Thank you

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

Inclusion Criteria:

- Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or

- 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

Type of Study:


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:


Principal Investigator

John D Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

August 2011

Related Keywords:

  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



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