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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Neoplasms, Squamous Cell	Drug: gefitinib (Iressa) Drug: cisplatin Radiation: radiotherapy Drug: Gefitinib (Iressa)	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Gefitinib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Local Disease Control Rate at 2 Years [ Time Frame: 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)). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Local Disease Control Rate at 1 Year [ Time Frame: 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). ] [ Designated as safety issue: No ]
Complete Response [ Time Frame: 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. ] [ Designated as safety issue: No ]
Tumour Response (Complete Response + Partial Response) [ Time Frame: 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 ] [ Designated as safety issue: No ]
Progression Free Survival [ Time Frame: 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) ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: Overall survival assessed at 2 years ] [ Designated as safety issue: No ]
Safety and Tolerability [ Time Frame: Assessed over two years ] [ Designated as safety issue: No ]

Enrollment:	224
Study Start Date:	November 2004
Study Completion Date:	June 2008

Arms	Assigned Interventions
Placebo Comparator: 1 Radiation + cisplatin; followed by placebo as maintenance therapy	Drug: cisplatin intravenous infusion Radiation: radiotherapy radiation therapy
Experimental: 2 250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy	Drug: gefitinib (Iressa) 250 mg oral tablet Other Names: ZD1839 IRESSA Drug: cisplatin intravenous infusion Radiation: radiotherapy radiation therapy
Experimental: 3 500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy	Drug: cisplatin intravenous infusion Radiation: radiotherapy radiation therapy Drug: Gefitinib (Iressa) 500 mg oral tablet Other Names: ZD1839 Iressa
Experimental: 4 gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy	Drug: gefitinib (Iressa) 250 mg oral tablet Other Names: ZD1839 IRESSA Drug: cisplatin intravenous infusion Radiation: radiotherapy radiation therapy
Experimental: 5 gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy	Drug: cisplatin intravenous infusion Radiation: radiotherapy radiation therapy Drug: Gefitinib (Iressa) 500 mg oral tablet Other Names: ZD1839 Iressa
Placebo Comparator: 6 placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy	Drug: gefitinib (Iressa) 250 mg oral tablet Other Names: ZD1839 IRESSA Drug: cisplatin intravenous infusion Radiation: radiotherapy radiation therapy
Placebo Comparator: 7 placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy	Drug: cisplatin intravenous infusion Radiation: radiotherapy radiation therapy Drug: Gefitinib (Iressa) 500 mg oral tablet Other Names: ZD1839 Iressa

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229723

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Oncology Medical Science Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00229723 History of Changes
Obsolete Identifiers:	NCT00099398
Other Study ID Numbers:	1839IL/0706, EudraCT number 2004-000358-21, D7919C00706
Study First Received:	September 28, 2005
Results First Received:	June 17, 2009
Last Updated:	June 17, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell Cancer
Squamous Cell Carcinoma
Squamous Cell Cancer

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Gefitinib

Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013