Esophageal Cancer Clinical Trial

Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer

Summary

The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer.

Side effects (toxicity) information will also be collected.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

62

Study ID:

NCT00393068

Recruitment Status:

Completed

Sponsor:

SCRI Development Innovations, LLC

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There are 9 Locations for this study

See Locations Near You

Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Integrated Community Oncology Network
Jacksonville Florida, 32256, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Consultants in Blood Disorders and Cancer
Louisville Kentucky, 40207, United States
Hematology Oncology Associates of Northern NJ
Morristown New Jersey, 07960, United States
Aultman Hospital
Canton Ohio, 44710, United States
Oncology Hematology Care
Cincinnati Ohio, 45242, United States
Chattanooga Oncology Hematology Associates
Chattanooga Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37023, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

62

Study ID:

NCT00393068

Recruitment Status:

Completed

Sponsor:


SCRI Development Innovations, LLC

How clear is this clinincal trial information?

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