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Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II


- Determine the 6-month overall survival of patients with metastatic adenocarcinoma of
the esophagus or gastroesophageal junction treated with cetuximab as second-line

- 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

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival at 6 Months

Outcome Time Frame:

every 3 weeks while on treatment, then every 3 months

Safety Issue:


Principal Investigator

Philip J. Gold, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus


United States: Federal Government

Study ID:




Start Date:

October 2004

Completion Date:

January 2010

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • recurrent esophageal cancer
  • stage IV esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



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Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
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James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
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Olympic Hematology and Oncology Bremerton, Washington  98310
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University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
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Polyclinic First Hill Seattle, Washington  98122
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Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
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