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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms, Squamous Cell

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Local Disease Control Rate at 2 Years

Outcome 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)).

Safety Issue:

No

Principal Investigator

AstraZeneca Oncology Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

1839IL/0706

NCT ID:

NCT00229723

Start Date:

November 2004

Completion Date:

June 2008

Related Keywords:

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

Name

Location
Research Site Boulder, Colorado  
Research Site Abilene, Texas