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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00242749
First received: October 20, 2005
Last updated: April 22, 2009
Last verified: April 2009
  Purpose

· 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 Intervention Phase
Cancer of Head and Neck
Drug: Gefitinib, Cisplatin and Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Disease-free survival at 2 years

Secondary Outcome Measures:
  • 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
  • PFS
  • Nature, incidence and severity of adverse events (AEs)
  • Overall survival

Estimated Enrollment: 47
Study Start Date: December 2002
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242749

Locations
Spain
Research Site
Badalona, Spain
Research Site
Murcia, Spain
Research Site
Málaga, Spain
Research Site
Santander, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00242749     History of Changes
Other Study ID Numbers: 1839IL/0102
Study First Received: October 20, 2005
Last Updated: April 22, 2009
Health Authority: Spain: Spanish Agency of Medicines

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:
Carcinoma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Gefitinib
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014