NCT00045526

Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

Phase II Study Of OSI-774 In Advanced Esophageal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.

Detailed description

PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib (erlotinib hydrochloride). II. Determine the overall survival of patients treated with this drug. III. Determine the degree of dysphagia relief in patients treated with this drug. IV. Determine the toxicity and tolerability of this drug in these patients. V. Correlate epidermal growth factor receptor (EGFR) expression with response to treatment in these patients. OUTLINE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Conditions

• Adenocarcinoma of the Esophagus
• Adenocarcinoma of the Gastroesophageal Junction
• Recurrent Esophageal Cancer
• Squamous Cell Carcinoma of the Esophagus
• Stage III Esophageal Cancer
• Stage IV Esophageal Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2002-06-01
• Primary completion: 2007-02-01
• First posted: 2003-01-27
• Last updated: 2013-06-04

Locations

1 site across 1 country: United States