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Completed

NCT Number: NCT00229723

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gefitinib (Iressa)

Drug

250 mg oral tablet

Other names: ZD1839, IRESSA

Cisplatin

Drug

intravenous infusion

Radiotherapy

Radiation

radiation therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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)).

  6. Safety and Tolerability

    Time frame: Assessed over two years

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2008
First posted
Sep 30, 2005
Registry last updated
Aug 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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