Phase 2
Completed N=226
IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
Neoplasms, Squamous Cell
Source: ClinicalTrials.gov NCT00229723 ↗
Enrolled (actual)
226
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Local Disease Control Rate at 2 Years — 21; 7; 15; 7 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Disease Control Rate at 2 Years |
21; 7; 15; 7; 7; 9 | — |
| SECONDARY Local Disease Control Rate at 1 Year |
27; 8; 16; 13; 10; 14 | — |
| SECONDARY Complete Response |
28; 7; 11; 13; 6; 14 | — |
| SECONDARY Tumour Response (Complete Response + Partial Response) |
34; 11; 17; 18; 11; 22 | — |
| SECONDARY Progression Free Survival |
41.9; 43.1; 58.1; 31.2; 43.1; 30.0 | — |
| SECONDARY Overall Survival |
64.6; 60.0; 74.8; 43.2; 49.4; 48.2 | — |
| SECONDARY Safety and Tolerability |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed stage III or IVA squamous cell carcinoma of the head and neck
- No prior surgery or chemotherapy/biological therapy/radiation therapy
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Life expectancy of more than 12 weeks
Exclusion Criteria
- Cancers of the nasal space, oral cavity and larynx; or certain lung diseases.
- Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal disease; or coexisting malignancies.
Data sourced from ClinicalTrials.gov (NCT00229723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.