NCT01243398

Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy

Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gefitinib (Iressa®) Versus Placebo in Esophageal Cancer Progressing After Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether gefitinib is more effective than a placebo in treating esophageal cancer. PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared with a placebo in treating patients with esophageal cancer that is progressing after chemotherapy.

Detailed description

OBJECTIVES: Primary * To assess whether gefitinib vs placebo will improve overall survival of patients with esophageal or gastroesophageal junction cancer. Secondary * To assess the toxicity of gefitinib monotherapy in these patients. * To assess whether gefitinib vs placebo will have a significant positive or negative impact upon quality of life of these patients. * To assess the impact gefitinib vs placebo will have on progression-free survival of these patients. OUTLINE: This is a multicenter study. * Arm A: Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. * Arm B: Patients receive oral placebo once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Blood samples are collected for genetic and translational studies. Patient's quality of life is assessed at baseline and periodically during the study with completion of EORTC Quality of Life Questionnaire (QLQ-C30) version 3.0. After completion of study treatment, patients are followed up every 8 weeks.

Conditions

• Adenocarcinoma of the Gastroesophageal Junction
• Esophageal Cancer

Interventions

Type	Name	Description
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-11-18
• Last updated: 2012-11-29

Locations

1 site across 1 country: United Kingdom