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
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
3 other identifiers
interventional
224
8 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2004
Typical duration for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 28, 2005
CompletedFirst Posted
Study publicly available on registry
September 30, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
August 4, 2009
CompletedAugust 4, 2009
June 1, 2009
September 28, 2005
June 17, 2009
June 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local Disease Control Rate at 2 Years
A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
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 (6)
Local Disease Control Rate at 1 Year
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).
Complete Response
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.
Tumour Response (Complete Response + Partial Response)
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
Progression Free Survival
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)
Overall Survival
Overall survival assessed at 2 years
- +1 more secondary outcomes
Study Arms (7)
1
PLACEBO COMPARATORRadiation + cisplatin; followed by placebo as maintenance therapy
2
EXPERIMENTAL250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
3
EXPERIMENTAL500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
4
EXPERIMENTALgefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
5
EXPERIMENTALgefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
6
PLACEBO COMPARATORplacebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
7
PLACEBO COMPARATORplacebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (25)
Research Site
Aurora, Colorado, United States
Research Site
Dallas, Texas, United States
Research Site
Brussels, Belgium
Research Site
Ghent, Belgium
Research Site
Leuven, Belgium
Research Site
Hradec Králové, Czechia
Research Site
Pardubice, Czechia
Research Site
Pilsen, Czechia
Research Site
Berlin, Germany
Research Site
Essen, Germany
Research Site
Münster, Germany
Research Site
Saarbrücken, Germany
Research Site
Bangalore, India
Research Site
Mumbai, India
Research Site
New Delhi, India
Research Site
Thiruvananthapuram, India
Research Site
Gliwice, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Lublin, Poland
Research Site
Warsaw, Poland
Research Site
Belgrade, Serbia
Research Site
Kamenitz, Serbia
Research Site
Taipei, Taiwan
Research Site
Taoynan, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca Oncology Medical Science Director, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 28, 2005
First Posted
September 30, 2005
Study Start
November 1, 2004
Study Completion
June 1, 2008
Last Updated
August 4, 2009
Results First Posted
August 4, 2009
Record last verified: 2009-06