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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

Primary Purpose

Neoplasms, Squamous Cell

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
gefitinib (Iressa)
cisplatin
radiotherapy
Gefitinib (Iressa)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Squamous Cell focused on measuring Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Cancer, Squamous Cell Carcinoma, Squamous Cell Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

1

2

3

4

5

6

7

Arm Description

Radiation + cisplatin; followed by placebo as maintenance therapy

250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy

500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy

gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy

gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy

placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy

placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Local Disease Control Rate at 1 Year
A patient demonstrated local disease control at 1 year 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.
Complete Response
A patient was deemed to be a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.
Tumour Response (Complete Response + Partial Response)
A patient was deemed to be have a tumour response if the RECIST criteria for complete response or partial response were satisfied at any time during the study.
Progression Free Survival
Percentage of participants who are progression free at 2 years (calculated using the Kaplan-Meier method, which allows for censored observations for example those lost to follow-up). A patient is said to have progressed if they have progression of target or non-target lesions or evidence of any new lesions (as defined by RECIST).
Overall Survival
Percentage of participants who are alive at 2 years (calculated using the Kaplan-Meier method, which allows for patients who do not have complete follow-up (censored observations)).
Safety and Tolerability

Full Information

First Posted
September 28, 2005
Last Updated
June 17, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00229723
Brief Title
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

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Squamous Cell
Keywords
Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Cancer, Squamous Cell Carcinoma, Squamous Cell Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Radiation + cisplatin; followed by placebo as maintenance therapy
Arm Title
2
Arm Type
Experimental
Arm Description
250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
Arm Title
3
Arm Type
Experimental
Arm Description
500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
Arm Title
4
Arm Type
Experimental
Arm Description
gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
Arm Title
5
Arm Type
Experimental
Arm Description
gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
Arm Title
6
Arm Type
Placebo Comparator
Arm Description
placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
Arm Title
7
Arm Type
Placebo Comparator
Arm Description
placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
Intervention Type
Drug
Intervention Name(s)
gefitinib (Iressa)
Other Intervention Name(s)
ZD1839, IRESSA
Intervention Description
250 mg oral tablet
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
intravenous infusion
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
radiation therapy
Intervention Type
Drug
Intervention Name(s)
Gefitinib (Iressa)
Other Intervention Name(s)
ZD1839, Iressa
Intervention Description
500 mg oral tablet
Primary Outcome Measure Information:
Title
Local Disease Control Rate at 2 Years
Description
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.
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)).
Secondary Outcome Measure Information:
Title
Local Disease Control Rate at 1 Year
Description
A patient demonstrated local disease control at 1 year 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.
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).
Title
Complete Response
Description
A patient was deemed to be a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.
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.
Title
Tumour Response (Complete Response + Partial Response)
Description
A patient was deemed to be have a tumour response if the RECIST criteria for complete response or partial response were satisfied at any time during the study.
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
Title
Progression Free Survival
Description
Percentage of participants who are progression free at 2 years (calculated using the Kaplan-Meier method, which allows for censored observations for example those lost to follow-up). A patient is said to have progressed if they have progression of target or non-target lesions or evidence of any new lesions (as defined by RECIST).
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)
Title
Overall Survival
Description
Percentage of participants who are alive at 2 years (calculated using the Kaplan-Meier method, which allows for patients who do not have complete follow-up (censored observations)).
Time Frame
Overall survival assessed at 2 years
Title
Safety and Tolerability
Time Frame
Assessed over two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Oncology Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Research Site
City
Pardubice
Country
Czech Republic
Facility Name
Research Site
City
Plzen
Country
Czech Republic
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Essen
Country
Germany
Facility Name
Research Site
City
Muenster
Country
Germany
Facility Name
Research Site
City
Saarbrucken
Country
Germany
Facility Name
Research Site
City
Bangalore
Country
India
Facility Name
Research Site
City
Mumbai
Country
India
Facility Name
Research Site
City
New Delhi
Country
India
Facility Name
Research Site
City
Thiruvananthapuram
Country
India
Facility Name
Research Site
City
Gliwice
Country
Poland
Facility Name
Research Site
City
Kraków
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Belgrade
Country
Serbia
Facility Name
Research Site
City
Sremska Kamenica
Country
Serbia
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Taoynan
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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