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OpenTrials
Completed

NCT Number: NCT00393068

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Florida Cancer Specialists, Fort Myers, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erlotinib

Drug

Erlotinib

Other names: Tarceva

Bevacizumab

Drug

Bevacizumab

Other names: Avastin

paclitaxel

Drug

Paclitaxel

Other names: Taxol

carboplatin

Drug

Carboplatin

Other names: Paraplatin

5-FU

Drug

5-FU

Other names: Fluorouracil

Radiation Therapy

Procedure

Radiation therapy

Surgery

Procedure

Surgery

Primary outcomes

  1. Pathologic Complete Response (pCR) Rate

    Time frame: 18 months

    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.

Secondary outcomes

  1. Overall Survival

    Time frame: 32 months

    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.

  2. Progression-Free Survival

    Time frame: 36 months

    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.

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Oct 26, 2006
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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