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

NCT00242749 | Completed Phase 2

• 1 other identifier: 1839IL/0102
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 4

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.

Conditions

Cancer of Head and Neck

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival at 2 years

Secondary Outcomes (4)

• 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

Interventions

Gefitinib, Cisplatin and Radiotherapy DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed squamous head and neck carcinoma
• Extra-laryngeal tumour or laryngeal tumour that is inoperable (not resectable) considered by Head and Neck Cancer Committee
• Stage III-IV (IVa and IVb) disease
• Measurable disease according to RECIST criteria
• Aged 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
• Normal renal, haematological (neutrophils \>1´5 x 109/ L and platelets \> 100 x 109/L) and liver function

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Badalona, Spain

Location

Research Site

Málaga, Spain

Location

Research Site

Murcia, Spain

Location

Research Site

Santander, Spain

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Gefitinib; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• AstraZeneca Spain Medical Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 21, 2005
• Study Start: December 1, 2002
• Study Completion: July 1, 2007
• Last Updated: April 23, 2009

Record last verified: 2009-04

Locations

ES (4)