drugset / Trial / NCT01185171

Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer

NCT01185171 ↗

Phase 2 Completed 70 enrolled University of Chicago
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to explore the activity of ZD1839 added to concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck cancer. Activity is described in terms of response rate (complete responses only).

Timeline

Start
2003-01-27
Primary completion
2018-07
Completion
2018-08

Outcome

Met primary endpoint

registry p < 0.01; proportion 0.88 (95% CI 0.77 to 0.95) NCT01185171 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefitinib Small molecule 500 mg Oral

Indications