Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Summary
RATIONALE: Erlotinib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This phase II trial is studying erlotinib to see how well it works in treating patients with advanced esophageal cancer or stomach cancer.
Description
OBJECTIVES:
- Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib.
- Determine the overall survival of patients treated with this drug.
- Determine the degree of dysphagia relief in patients treated with this drug.
- Determine the toxicity and tolerability of this drug in these patients.
- Correlate epidermal growth factor receptor (EGFR) expression with response to treatment in these patients.
OUTLINE: This is a non-randomized study. Patients are stratified according to epidermal growth factor receptor status (positive vs negative).
Patients receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-48 patients (9-24 per stratum) will be accrued for this study within 2 years.
Study Design
Allocation: Non-Randomized, Control: Active Control, Primary Purpose: Treatment
Conditions
Esophageal Cancer
Intervention
erlotinib hydrochloride
Location
Memorial Sloan-Kettering Cancer Center
New York
New York
United States
10021
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00045526
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:55:47-0400
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Medical and Biotech [MESH] Definitions
Erlotinib Hydrochloride
A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.
Esophageal Neoplasms
Tumors or cancer of the ESOPHAGUS.
Diverticulosis, Esophageal
A pathological condition characterized by the presence of a number of ESOPHAGEAL DIVERTICULA in the ESOPHAGUS.
Esophageal Mucosa
Circular innermost layer of the ESOPHAGUS wall that mediates esophageal PERISTALSIS which pushes ingested food bolus toward the stomach.
Esophageal Motility Disorders
Disorders affecting the motor function of the UPPER ESOPHAGEAL SPHINCTER; LOWER ESOPHAGEAL SPHINCTER; the ESOPHAGUS body, or a combination of these parts. The failure of the sphincters to maintain a tonic pressure may result in gastric reflux of food and acid into the esophagus (GASTROESOPHAGEAL REFLUX). Other disorders include hypermotility (spastic disorders) and markedly increased amplitude in contraction (nutcracker esophagus).
