Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer

November 7, 2014 updated by: Peter C. Enzinger, MD, Dana-Farber Cancer Institute

Phase II Trial of Cetuximab, Irinotecan, Cisplatin (CPC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer

The purpose of this study is to find out what effects (good and bad) the combination of three chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when given with radiation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Patients participating in this study must have a tumor biopsy taken to confirm the type of tumor.
  • Outpatient therapy with cetuximab alone will be given intravenously on week 0.
  • During week 1-8 outpatient radiation therapy will be started and continued once per day for 28 treatments or 5 1/2 weeks.
  • Outpatient chemotherapy (cisplatin, irinotecan and cetuximab) is given once per week on weeks 1, 2, 4, and 5. Cetuximab alone will be given on weeks 3, 6, 7, and 8.
  • A repeat CT scan and PET scan will be performed to restage the tumor on week 8. This is to confirm that the cancer has remained localized.
  • Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and radiation therapy.
  • Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6 months.
  • During chemotherapy and radiation therapy, physical exams and vital signs will be performed before each chemotherapy treatment. Routine blood tests will also be performed.
  • Between chemotherapy-radiation therapy and surgery a CAT scan of chest, abdomen and pelvis along with a PET scan will be performed.
  • After surgery a CAT scan of chest, abdomen and pelvis will be performed every 3 months for 2 years then every 6 months for 3 years. An EGD (upper endoscopy) with biopsy will be done every 6 months for 2 years and then yearly for 3 years. Physical exam, vital signs and routine blood tests will be done every 2 weeks for 6 months, then every 3 months for 1.5 years, and then every 6 months for 3 years.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Negative pregnancy test
  • Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, stage IIA, IIB and III.
  • ECOG performance status of 0 or 1.
  • Neutrophils greater or equal to 1,500/ul
  • Platelets greater or equal to 100,000/ul
  • Serum bilirubin less or equal to 1.5mg/ul
  • Serum creatinine less or equal to 1.5mg/ul
  • AST or SGOT less or equal to 2.5x upper normal limit
  • Alkaline phosphatase less or equal to 5x upper normal limit

Exclusion Criteria:

  • Prior surgery for esophageal or gastro-esophageal junction cancer.
  • Prior chemotherapy or radiation therapy
  • Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula.
  • Metastatic disease to distant organs or non-regional lymph nodes.
  • Co-morbid disease that in the opinion of the investigator makes combined chemo-radiotherapy inadvisable.
  • Pregnant or lactating women
  • Other active malignancy
  • Patients with known Gilbert's Disease or interstitial pulmonary fibrosis.
  • History of seizure disorder
  • Uncontrolled diarrhea
  • Peripheral neuropathy (Grade 2)
  • Prior cetuximab or other therapy that specifically and directly targets the EGF pathway.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the safety of the drug combination and radiation therapy
Time Frame: 3 years
3 years
To determine the progression-free survival of patients treated with combination chemotherapy and radiation therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Peter Enzinger, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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