S0415 Cetuximab 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.

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Not specified

Renal

- Creatinine ≤ 1.5 times upper limit of normal

Other

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior cetuximab

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy and recovered

- No concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- At least 4 weeks since prior radiotherapy and recovered

Surgery

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

Other

- No other prior therapy that specifically targets the epidermal growth factor pathway

- No other concurrent investigational agents