IRESSA in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00242749
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : April 23, 2009
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Brief Summary:
· To evaluate the disease free survival rate at 2 years of patients with advanced head and neck carcinoma treated with ZD1839 250 mg administered once daily in combination with cisplatin and a standard course of radiotherapy.

Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Drug: Gefitinib, Cisplatin and Radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial to Evaluate ZD1839 (IRESSA) in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma (Unresectable &Inoperable)
Study Start Date : December 2002
Actual Study Completion Date : July 2007

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U.S. FDA Resources

Primary Outcome Measures :
  1. Disease-free survival at 2 years

Secondary Outcome Measures :
  1. Objective tumour response (CR and PR) at 6 months after the start of treatment based on the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
  2. PFS
  3. Nature, incidence and severity of adverse events (AEs)
  4. Overall survival

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242749

Research Site
Badalona, Spain
Research Site
Murcia, Spain
Research Site
Málaga, Spain
Research Site
Santander, Spain
Sponsors and Collaborators
Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca Identifier: NCT00242749     History of Changes
Other Study ID Numbers: 1839IL/0102
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action