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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393068
• Other study ID #: SCRI GI 91
• Status: Completed
• Phase: Phase 2
• Start date: February 2007
• Est. completion date: August 2011

Study information

• Verified date: February 2022
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Erlotinib
Erlotinib
• Bevacizumab
Bevacizumab
• Paclitaxel
Paclitaxel
• Carboplatin
Carboplatin
• 5-FU
5-FU

Procedure:
• Radiation therapy
Radiation therapy
• Surgery
Surgery

Locations

Country	Name	City	State
United States	Aultman Hospital	Canton	Ohio
United States	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	Hematology Oncology Associates of Northern NJ	Morristown	New Jersey
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bendell JC, Meluch A, Peyton J, Rubin M, Waterhouse D, Webb C, Burris HA 3rd, Hainsworth JD. A phase II trial of preoperative concurrent chemotherapy/radiation therapy plus bevacizumab/erlotinib in the treatment of localized esophageal cancer. Clin Adv Hematol Oncol. 2012 Jul;10(7):430-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response (pCR) Rate	pCR was defined as no residual viable cancer found at the primary site or regional lymph nodes upon pathologic review of the surgical specimen for patients who went to surgical resection.	18 months
Secondary	Overall Survival	Overall Survival (OS) is defined as the time interval from the start of treatment until death. Patients who remained alive were censored at the date of their last tumor assessment.	32 months
Secondary	Progression-Free Survival	Progression-free survival (PFS) was defined as the interval from the date of first treatment until the date of disease progression or death, whichever occurred first. Patients who did not progress were censored at the date of their last tumor assessment.	36 months