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A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Neoplasms

Thank you

Trial Information

A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer


Inclusion Criteria:



- Histologically confirmed head and neck cancer

- Lymph node negative or positive

- Metastasis negative

- Chemo- and radiotherapy naïve

- WHO 0-2

- Measurable disease by RECIST

- Written informed consent

Exclusion Criteria:

- Severe alcohol abuse

- Active ILD

- Co-existing chronic gastrointestinal disease(s)

- Brain metastasis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Parts 1 and 2: Safety (Incidence of DLTs)

Principal Investigator

AstraZeneca Finland Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Finland: Finnish Medicines Agency

Study ID:

1839IL/0151

NCT ID:

NCT00239304

Start Date:

June 2003

Completion Date:

March 2006

Related Keywords:

  • Head and Neck Neoplasms
  • Stage III Head and Neck Cancer
  • Stage IV Head and Neck Cancer
  • Neoplasms
  • Head and Neck Neoplasms

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