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

June 17, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: cisplatin
intravenous infusion
Radiation: radiotherapy
radiation therapy
Drug: gefitinib (Iressa)
250 mg oral tablet
Other Names:
  • ZD1839
  • IRESSA
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:
  • Iressa
  • ZD1839
Experimental: 4
gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
Drug: cisplatin
intravenous infusion
Radiation: radiotherapy
radiation therapy
Drug: gefitinib (Iressa)
250 mg oral tablet
Other Names:
  • ZD1839
  • IRESSA
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:
  • Iressa
  • ZD1839
Placebo Comparator: 6
placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
Drug: cisplatin
intravenous infusion
Radiation: radiotherapy
radiation therapy
Drug: gefitinib (Iressa)
250 mg oral tablet
Other Names:
  • ZD1839
  • IRESSA
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:
  • Iressa
  • ZD1839

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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
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.
A patient was deemed to be a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.
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)
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
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.
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
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)
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).
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
Time Frame: Overall survival assessed at 2 years
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)).
Overall survival assessed at 2 years
Safety and Tolerability
Time Frame: Assessed over two years
Assessed over two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Oncology Medical Science Director, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 28, 2005

First Submitted That Met QC Criteria

September 28, 2005

First Posted (Estimate)

September 30, 2005

Study Record Updates

Last Update Posted (Estimate)

August 4, 2009

Last Update Submitted That Met QC Criteria

June 17, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0706
  • EudraCT number 2004-000358-21
  • D7919C00706

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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