CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 224 enrolled
Drug / intervention
gefitinib (Iressa) +3 moredrug
Likely dose
Gefitinib 250 mg or 500 mg orally, given continuously or concomitantly with cisplatin and radiotherapyAI-extracted
Key inclusion· 4
  • ✓Histologically or cytologically confirmed stage III or IVA squamous cell carcinoma of the head and neck
  • ✓No prior surgery, chemotherapy, biological therapy, or radiation therapy
  • ✓Measurable disease by RECIST criteria
  • ✓Life expectancy greater than 12 weeks
Key exclusion· 5
  • ✕Cancers of the nasal space, oral cavity, or larynx
  • ✕Certain lung diseases
  • ✕Abnormal blood chemistry
  • ✕Uncontrolled respiratory, cardiac, hepatic, or renal disease

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

Search/NCT00229723
NCT00229723Phase 2Completed
CompareCT.gov

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multicentre Comparative Study of Gefitinib 250 mg or 500 mg (IRESSA™) Given Either Continuously or Concomitantly With Cisplatin Plus Radiotherapy for the Treatment of Patients With Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma

AstraZeneca·interventional·Posted Sep 30, 2005·Updated Aug 4, 2009

In Brief

A Phase 2 clinical trial evaluating gefitinib (Iressa), cisplatin, and 2 other interventions for Neoplasms, Squamous Cell. Completed, enrolled 224 participants across 25 sites in 8 countries.

Detailed Summary

The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Squamous Cell
CountriesBelgium, Czechia, Germany, India, Poland, Serbia, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 30, 2005
Enrollment StartNov 1, 2004
Study CompletionJun 1, 2008
TodayJul 2, 2026
Posted 20.8 years ago

Interventions

gefitinib (Iressa)drug

250 mg oral tablet

cisplatindrug

intravenous infusion

radiotherapyradiation

radiation therapy

Gefitinib (Iressa)drug

500 mg oral tablet