Clinical trial NCT00242749: IRESSA in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-21
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Disease-free survival at 2 years
Secondary outcomes:
measure: 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
measure: PFS
measure: Nature, incidence and severity of adverse events (AEs)
measure: Overall survival
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Spain Medical Director, MD
role: STUDY_DIRECTOR
References: