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Iressa + Cisplatin + Radiation in Head and Neck Cancer
NCT00195078Phase 2
Key facts
- Status
- Terminated
- Start
- Apr 2004
- Countries
- 1
- Sponsor
- Weill Cornell Medicine
- Modality
- Small Molecules
- Drugs
- gefitinib
- Conditions
- squamous cell carcinoma of the head and neck (HNSCC)
01
Overview
Phase 2, open-label, single-arm trial of gefitinib in squamous cell carcinoma of the head and neck (HNSCC), sponsored by Weill Cornell Medicine. Primary endpoint: Clinical Complete Response Rate. Started Apr 2004; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Iressa + Cisplatin + Radiation
Daily ZD1839 (Iressa) during a course of standard radiation therapy accompanied by cisplatin.
03
Who it enrols
Adults with Stage III-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, ECOG <= 1, life expectancy > 6 months, no prior cancer treatment.
04
Endpoints
Primary
Clinical Complete Response Rate
Secondary
Time to Disease Progression
Duration of Response
2-Year Disease-Free Survival
Toxicities
Dose-Limiting Toxicity
Recommended Phase II Dose
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