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 : May 1, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

November 9, 2004
November 9, 2004
April 4, 2012
May 1, 2012
May 1, 2012
October 2004
January 2008   (Final data collection date for primary outcome measure)
Overall Survival at 6 Months [ Time Frame: every 3 weeks while on treatment, then every 3 months ]
Not Provided
Complete list of historical versions of study NCT00096031 on Archive Site
  • Time to Treatment Failure [ Time Frame: every 3 weeks while on treatment ]
  • Time to Progression [ Time Frame: every 3 weeks while on treatment, then every 3 months for 3 years ]
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S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II

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.


  • 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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Esophageal Cancer
Biological: cetuximab
1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.
Other Name: Erbitux
Experimental: Cetuximab
250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
Intervention: Biological: cetuximab
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
January 2010
January 2008   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
S0415 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Southwest Oncology Group
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
Southwest Oncology Group
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP