A Phase II Randomised, Double-blind, Placebo-controlled, Multicentre Comparative study of ZD1839 250 mg or 500 mg (Iressatm) given either continuously or concomitantly with cisplatin plus radiotherapy for the treatment of patients with previously untreated unresected late stage III/IV non-metastatic head and neck squamous cell carcinoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 224

Inclusion Criteria

1.Provision of written informed consent
2.Female or male patients aged 18 years and over
3.Patients must have measurable disease according to RECIST
4.Presence of stage III or IVA (Appendix L) squamous cell carcinoma of the head and neck confirmed histologically by biopsy or by fine needle aspiration at the time of diagnosis
5.No previous surgery to the tumour except for biopsy and not scheduled for surgery
6.No previous chemotherapy or radiotherapy for any neoplasm/tumour
7.No previous anti-EGFR therapy
8.Life expectancy ³12 weeks.
9.World Health Organisation (WHO) Performance Status of 0 or 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Buccal mucosal carcinomas and post-nasal space (nasopharyngeal carcinoma), thyroid, sinus or salivary gland tumours and Grade III laryngeal carcinoma
2.Early stage III cancers (T1N1 or T2N1), Extensive disease (T4b) or metastatic disease (M1)
3.Disease invading the mandible
4.The presence of simultaneous primary tumours
5.Known severe hypersensitivity to ZD1839 or any of the excipients of this product
6.Known severe hypersensitivity to cisplatin or any of the excipients of this product
7.Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
8.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
9.Absolute neutrophil counts (ANC) £1.0 x 109/litre (L) or platelets £100 x 109/L
10.Serum bilirubin ³3 times the upper limit of the reference range (ULRR)
11.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULRR
12.Calculated creatinine clearance (Cockcroft and Gault) £60 ml/min
13.Serum calcium above the ULRR
14.As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
15.Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
16.Pregnancy or breastfeeding.
17.Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, amifostine, erythropoietin or St. John’s Wort
18.Concomitant use of CYP3A4 inhibitors (e.g., itraconazole)
19.Treatment with a non-approved or investigational drug within 30 days before
Day 1 of study treatment
20.Evidence of ototoxicity or other neurotoxicity
21.Concurrent treatment with other experimental drugs and/or anticancer agents

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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