Completed

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

What is being tested

Erlotinib

+ Bevacizumab

+ Paclitaxel

DrugProcedure

Who is being recruted

Digestive System Diseases+6

+ Digestive System Neoplasms

+ Esophageal Diseases

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: February 2007

See protocol details

Summary

Principal SponsorSCRI Development Innovations, LLC

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2007

Actual date on which the first participant was enrolled.

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.

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

NCT00393068

Principal SponsorSCRI Development Innovations, LLC

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

62 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesEsophageal NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by Site

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Suspended

Florida Cancer Specialists

Fort Myers, United StatesOpen Florida Cancer Specialists in Google Maps

Suspended

Integrated Community Oncology Network

Jacksonville, United States

Suspended

Northeast Georgia Medical Center

Gainesville, United States

Suspended

Consultants in Blood Disorders and Cancer

Louisville, United States

Completed9 Study Centers