Cetuximab, Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

June 8, 2012 updated by: Swiss Group for Clinical Cancer Research

Cetuximab in Combination With Radiation Therapy and Chemotherapy Prior to Surgery in Patients With Resectable, Locally Advanced Esophageal Carcinoma. A Multicenter Phase IB-II Trial

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab, docetaxel, and cisplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I/II trial is studying the side effects of cetuximab, docetaxel, cisplatin, and radiation therapy and to see how well they work in treating patients with locally advanced esophageal cancer that can be removed by surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin in patients with resectable locally advanced esophageal cancer.

Secondary

  • Determine the feasibility and efficacy of this regimen in these patients.
  • Determine the duration of response and patterns of failure in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Chemoimmunotherapy: Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-3 and docetaxel IV over 1 hour and cisplatin IV over 1 hour once in week 1. Treatment repeats every 3 weeks for 2 courses.

  • Chemoimmunotherapy and radiotherapy: Patients are sequentially assigned to 1 of 2 treatment levels.

    • Treatment level 1: Patients receive cetuximab IV over 1 hour once weekly, cisplatin IV over 1 hour once weekly, and undergo radiotherapy once daily, 5 days a week, in weeks 7-11.
    • Treatment level 2: Patients receive cetuximab, cisplatin, and radiotherapy as in treatment level 1. Patients also receive docetaxel IV over 1-2 hours once weekly in weeks 7-11.

Cohorts of 7-20 patients are treated at treatment level 1 or 2 sequentially, as long as no more than 2 of 7 patients experience dose-limiting toxicity (DLT), until the safe treatment level for future study is determined. The safe treatment level is defined as the level at which no more than 2 of 7 and no more than 6 of 20 patients experience DLT. At least 20 patients are treated at the safe treatment level.

  • Surgery: Between 4-8 weeks after completion of neoadjuvant chemoimmunotherapy and radiotherapy, patients undergo surgery.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2
  • Phase 1

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

  • Switzerland
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
      • St. Gallen, Switzerland, Ch-9016
        • Klinik Stephanshorn

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus

    • Carcinoma of the gastroesophageal junction (i.e., Siewert staging system type I disease) allowed

  • Locally advanced disease

    • Obstructive tumors are considered locally advanced disease

    • Meets 1 of the following staging criteria:

      • T3, N0 disease
      • T1-3, N1 disease
      • T4, N0-1 disease

  • Resectable disease

    • No T4 (unequivocal organ involvement) disease that cannot be resected with curative intent
  • No airway infiltration in case of tumors of the upper third of the thoracic esophagus
  • No cervical esophageal carcinoma
  • No distant metastasis, including stage M1a (celiac node involvement) by fine-needle aspiration or biopsy

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Creatinine clearance > 60 mL/min
  • Bilirubin normal
  • Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
  • AST ≤ 1.5 times ULN
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • No other malignancy within the past 5 years except nonmelanomatous skin cancer or adequately treated in situ cervical cancer

  • No severe or uncontrolled cardiovascular disease including, but not limited to, any of the following:

    • New York Heart Association class III or IV congestive heart failure
    • Unstable angina pectoris
    • Myocardial infarction within the past 3 months
    • Significant arrhythmias
  • No psychiatric disorder that would preclude study compliance
  • No active uncontrolled infection
  • No serious underlying medical condition that, in the opinion of the investigator, would interfere with study participation (e.g., uncontrolled diabetes mellitus or active autoimmune disease)
  • No peripheral neuropathy > grade 1
  • No contraindications to corticosteroids
  • No known hypersensitivity to any component of the study drugs

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No prior radiotherapy to the chest
  • No participation in another clinical trial within the past 30 days
  • No other concurrent experimental drugs or anticancer therapy
  • No concurrent drugs contraindicated for use with the study drugs

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
Measure Description
Time Frame
Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin
Time Frame: Until treatment ends
Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin
Until treatment ends

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the feasibility and efficacy of the study's regimen
Time Frame: Until trial ends
Determine the feasibility and efficacy of this regimen in these patients.
Until trial ends
Determine the duration of response and patterns of failure
Time Frame: Until trial ends
Determine the duration of response and patterns of failure in patients treated with this regimen
Until trial ends

Collaborators and Investigators

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

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

  • Study Chair: Thomas Ruhstaller, MD, Cantonal Hospital of St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 9, 2007

Study Record Updates

Last Update Posted (Estimate)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 8, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 75/06
  • EU-20702

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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