Know Cancer

forgot password

A Phase 2 Trial to Evaluate ZD1839 (IRESSA) in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma (Unresectable &Inoperable)

Phase 2
18 Years
70 Years
Not Enrolling
Cancer of Head and Neck

Thank you

Trial Information

A Phase 2 Trial to Evaluate ZD1839 (IRESSA) in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma (Unresectable &Inoperable)

Inclusion Criteria:

1. Histologically confirmed squamous head and neck carcinoma

2. Extra-laryngeal tumour or laryngeal tumour that is inoperable (not resectable)
considered by Head and Neck Cancer Committee

3. Stage III-IV (IVa and IVb) disease

4. Measurable disease according to RECIST criteria

5. Aged 18 years or older

6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

7. Normal renal, haematological (neutrophils >1´5 x 109/ L and platelets > 100 x 109/L)
and liver function

Exclusion Criteria:

- 1. Previous treatment for initial disease (neck dissection in N3 is allowed) 2. Other
co-existing malignancies or malignancies diagnosed within the last 5 years with the
exception of basal cell carcinoma or cervical cancer in situ 3. Incomplete healing
from previous oncologic or other surgery 4. Absolute neutrophil count (ANC) less than
1.5 x 109/ L, or platelets less than 100x 109/L 5. Serum bilirubin greater than 1.25
times the upper limit of reference range (ULRR) 6. In the opinion of the
investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable
or uncompensated respiratory, cardiac, hepatic or renal disease) 7. Serum creatinine
greater than 1.25 times the ULRR 8. ALT or AST greater than 2.5 times the ULRR 9.
Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the patient to participate in the trial 10. Active dermatoses
(e.g. psoriasis, eczema) 11. Corneal abnormalities (other than scars, congenital
abnormality or corneal tear film), history of dry eye syndrome or ocular surface
diseases and neurological disorders 12. Concomitant use of phenytoin, carbamazepine,
barbiturates, rifampicin or drugs with known corneal toxicity 13. Pregnancy or
breastfeeding (women of child-bearing potential) 14. Patient incapacity to reliably
follow the treatment or follow up for family, economic or geographical reasons.

Type of Study:


Study Design:

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

Outcome Measure:

Disease-free survival at 2 years

Principal Investigator

AstraZeneca Spain Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:



Spain: Spanish Agency of Medicines

Study ID:




Start Date:

December 2002

Completion Date:

July 2007

Related Keywords:

  • Cancer of Head and Neck
  • Head and Neck Cancer Disease
  • Head Cancer
  • Neck Cancer
  • Cancer of Head
  • Cancer of Neck
  • Cancer of the Head
  • Cancer of the Head and Neck
  • Cancer of the Neck
  • Neoplasms, Head and Neck
  • Carcinoma
  • Head and Neck Neoplasms