Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI SWOG-S0415 S0415, NCT00096031

Objectives

1. Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy.
2. Determine the response rate (confirmed and unconfirmed, complete and partial), time to progression, and time to treatment failure in patients treated with this drug.
3. Determine the toxicity of this drug in these patients.
4. 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.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 30-55 patients will be accrued for this study within 6-14 months.

Outcomes

Overall survival at 6 months

Time to treatment failure
Time to progression

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.

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Philip Gold, MD, Protocol chair		Ph: 206-386-2121 Email: philip.gold@swedish.org
Syma Iqbal, MD, Protocol co-chair		Ph: 323-865-3907; 800-865-0102 Email: iqbal@usc.edu

Registry Information
Official Title		Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II
Trial Start Date		2004-10-15
Registered in ClinicalTrials.gov		NCT00096031
Date Submitted to PDQ		2004-09-09
Information Last Verified		2007-01-01
NCI Grant/Contract Number		CA32102

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