NCT00096031

S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab	1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.

Timeline

• Start date: 2004-10-01
• Primary completion: 2008-01-01
• Completion: 2010-01-01
• First posted: 2004-11-09
• Last updated: 2018-09-26
• Results posted: 2012-05-01

Locations

152 sites across 1 country: United States