CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Gefitinibdrug
Likely dose
Gefitinib 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00519077
NCT00519077Phase 2Completed
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Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) as Monotherapy in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

University of Chicago·interventional·Posted Aug 21, 2007·Updated Jul 1, 2016

In Brief

A Phase 2 clinical trial evaluating Gefitinib for Head and Neck Neoplasms. Completed, enrolled 44 participants across 2 sites.

Detailed Summary

The purpose of this study is to demonstrate the activity (response rate and rate of stable disease) of Iressa administered as a single agent escalated to a dose that produces grade 2 skin toxicity in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Neoplasms
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 21, 2007
Enrollment StartMar 1, 2005
Primary CompletionMay 1, 2008
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.9 years ago

Interventions

Gefitinibdrug

Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.