S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00096031
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : May 1, 2012
Last Update Posted : July 31, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Biological: cetuximab Phase 2

Detailed Description:


  • Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy.
  • Determine the response rate (confirmed and unconfirmed, complete and partial), time to progression, and time to treatment failure in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Correlate, preliminarily, gene expression and germline polymorphism of enzymes and genes involved in the epidermal growth factor receptor pathway, DNA repair, and angiogenesis with time to progression, response, overall survival, toxic effects, and time to treatment failure in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on day 1. Treatment repeats once weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months until 3 years from the date of study registration.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 6-14 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II
Study Start Date : October 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Cetuximab
250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
Biological: cetuximab
1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.
Other Name: Erbitux

Primary Outcome Measures :
  1. Overall Survival at 6 Months [ Time Frame: every 3 weeks while on treatment, then every 3 months ]
    Time to death is measured from date of registration to date of death due to any cause.

Secondary Outcome Measures :
  1. Time to Treatment Failure [ Time Frame: every 3 weeks while on treatment ]
    Time to treatment failure is measured from date of registration to date of first observation of progressive disease (as defined in the protocol), death due to any cause, symptomatic deterioration (as defined in the protocol), or early discontinuation of treatment.

  2. Time to Progression [ Time Frame: every 3 weeks while on treatment, then every 3 months for 3 years ]
    Progression free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration (as defined in the protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of 1 of the following sites:

    • Thoracic esophagus, located > 20 cm* from the incisors
    • Gastroesophageal junction, located ≤ 2 cm into the gastric cardia NOTE: *Tumors located < 26 cm from the incisors must be confirmed by bronchoscopy and negative cytology
  • Disease confined to the esophagus and periesophageal soft tissue
  • Metastatic disease
  • Measurable disease by x-ray, scanning, or physical examination
  • Received exactly 1 prior chemotherapy regimen for metastatic or recurrent disease

    • One prior adjuvant or neoadjuvant chemotherapy regimen allowed if administered at the time of initial diagnosis with localized disease
  • No known brain metastases



  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Not specified


  • Creatinine ≤ 1.5 times upper limit of normal


  • No prior allergic reaction to chimerized or murine monoclonal antibodies
  • No evidence of human anti-mouse antibodies (HAMA)
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy

  • No prior cetuximab


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered


  • At least 3 weeks since prior thoraco-abdominal surgery and recovered


  • No other prior therapy that specifically targets the epidermal growth factor pathway
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00096031

  Show 152 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Philip J. Gold, MD Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Study Chair: Syma Iqbal, MD University of Southern California

Publications of Results:
Gold PJ, Goldman B, Iqbal S, et al.: Cetuximab as second-line therapy in patients with metastatic esophageal cancer: a phase II Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-96, 2008.

Responsible Party: Southwest Oncology Group Identifier: NCT00096031     History of Changes
Other Study ID Numbers: CDR0000391201
S0415 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2004    Key Record Dates
Results First Posted: May 1, 2012
Last Update Posted: July 31, 2018
Last Verified: July 2018

Keywords provided by Southwest Oncology Group:
adenocarcinoma of the esophagus
recurrent esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents