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A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Carcinoma, Squamous Cell

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Trial Information

A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck


Inclusion Criteria:



- Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck

- At least one measurable tumour lesion

Exclusion Criteria:

- No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma
Head and Neck

- No other co-existing malignancies or malignancies diagnosed within the last 5 years
with the exception of basal cell carcinoma or cervical cancer in situ

- Any evidence of severe or uncontrolled systemic disease (e.g. unstable or
uncompensated respiratory, cardiac, hepatic or renal disease)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.

Principal Investigator

AstraZeneca Italy Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Italy: The Italian Medicines Agency

Study ID:

1839IL/0070

NCT ID:

NCT00233636

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Carcinoma, Squamous Cell
  • Squamous Cell Carcinoma of Head and Neck
  • Inoperable locally advanced Squamous Cell Carcinoma of Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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