Clinical trial NCT00229723: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms, Squamous Cell
Keywords: Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell Cancer
Squamous Cell Carcinoma
Squamous Cell Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-30
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Local Disease Control Rate at 2 Years
timeFrame: Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).
Secondary outcomes:
measure: Local Disease Control Rate at 1 Year
timeFrame: Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST).
measure: Complete Response
timeFrame: Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression.
measure: Tumour Response (Complete Response + Partial Response)
timeFrame: Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression
measure: Progression Free Survival
timeFrame: Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST)
measure: Overall Survival
timeFrame: Overall survival assessed at 2 years
measure: Safety and Tolerability
timeFrame: Assessed over two years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Brussels
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Muenster
country: Germany
facility: Research Site
city: Saarbrucken
country: Germany
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Thiruvananthapuram
country: India
facility: Research Site
city: Gliwice
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Sremska Kamenica
country: Serbia
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoynan
country: Taiwan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Oncology Medical Science Director, MD
role: STUDY_DIRECTOR
References: