Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Philip J. Gold

Study Chair

Syma Iqbal

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00096031
Information obtained from ClinicalTrials.gov on December 14, 2011

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