Esophageal Cancer Clinical Trial
Official title:
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.
OBJECTIVES:
- 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.
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