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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229723
• Other study ID #: 1839IL/0706
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2005
• Last updated: June 17, 2009
• Start date: November 2004
• Est. completion date: June 2008

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00099398

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Neoplasms, Squamous Cell

Intervention

Drug:
• gefitinib (Iressa)
250 mg oral tablet
• cisplatin
intravenous infusion

Radiation:
• radiotherapy
radiation therapy

Drug:
• Gefitinib (Iressa)
500 mg oral tablet

Locations

Country	Name	City	State
Belgium	Research Site	Brussels
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Pardubice
Czech Republic	Research Site	Plzen
Germany	Research Site	Berlin
Germany	Research Site	Essen
Germany	Research Site	Muenster
Germany	Research Site	Saarbrucken
India	Research Site	Bangalore
India	Research Site	Mumbai
India	Research Site	New Delhi
India	Research Site	Thiruvananthapuram
Poland	Research Site	Gliwice
Poland	Research Site	Kraków
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Warszawa
Serbia	Research Site	Belgrade
Serbia	Research Site	Sremska Kamenica
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoynan
United States	Research Site	Aurora	Colorado
United States	Research Site	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Germany,  India,  Poland,  Serbia,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Disease Control Rate at 2 Years		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)).	No
Secondary	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).	No
Secondary	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.	No
Secondary	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	No
Secondary	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)	No
Secondary	Overall Survival		Overall survival assessed at 2 years	No
Secondary	Safety and Tolerability		Assessed over two years	No