A PHASE III RANDOMISED, STRATIFIED, PARALLEL-GROUP, MULTI-CENTRE, COMPARATIVE STUDY OF ZD1839 (IRESSA®) 250 MG AND 500 MG VERSUS METHOTREXATE FOR PREVIOUSLY TREATED PATIENTS WITH SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK - IMEX

• Conditions: squamous cell carcinoma of the head and neck

• Registration Number: EUCTR2004-002662-38-EE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 477

Inclusion Criteria

1.provision of informed consent
2.female or male patients aged 18 years and over
3.histological confirmation of evidence of squamous cell carcinoma of the head and neck diagnosed by biopsy or fine needle aspiration (FNA) at initial presentation
4.Stratum A:
Patients must have had radiotherapy or chemoradiotherapy as primary treatment and must have received at least a course of 2 cycles of platinum-based chemotherapy for recurrent disease and response to the most recent course of platinum-based chemotherapy must have been either progressive disease (radiologically documented) orstable disease (radiologically documented) after at least 2 cycles of platinum based chemotherapy.
or
Stratum B. Patients whose tumours have progressed after primary treatment with radiation or chemoradiation and are considered unsuitable for platinum-based chemotherapy, due to performance status 2, decreased creatinine clearance, cardiac status or refusal of such chemotherapy (by the investigator) due to potential toxicity.
5.no prior anti-EGFR or methotrexate therapy
6.life expectancy ³8 weeks
7.WHO Performance Status 0, 1 or 2

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumours
2.isolated recurrent disease that may be amenable to local therapy eg, surgical intervention or radiation therapy
3.known severe hypersensitivity to ZD1839, methotrexate or any of the excipients of these products
4.other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
5.any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
6.any third space accumulation of fluid (oedema, effusion, ascites)
7.absolute neutrophil counts =1.5 x 109/L or platelets =100 x 109/L
8.serum bilirubin =1.25 times the upper limit of the reference range (ULRR)
9.alanine aminotransferase (ALT/SGPT) or aspartate aminotransferase (AST/SGOT) > 2.5 times the ULRR if no demonstrable liver metastases, or > 5 times the ULRR in the presence of liver metastases
10.evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
11.as judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
12.evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
13.pregnancy or breast feeding (women of child-bearing potential)
14.concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John’s Wort
15.treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
16.intra-cerebral metastases unless diagnostic imaging demonstrates no peritumoural oedema or progression since last scan (with at least 4-6 weeks between scans), the patient does not require corticosteroids, and the patient is asymptomatic from the metastases
17.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
Main Objective: To compare ZD1839 (250 mg and 500 mg) versus methotrexate in terms of overall survival;Secondary Objective: 1. To compare ZD1839 (250 mg and 500 mg) versus methotrexate in terms of symptom improvement<br>2. To compare ZD1839 (250 mg and 500 mg) versus methotrexate in terms of overall objective tumour response (CR + PR) using RECIST criteria<br>3. To compare ZD1839 (250 mg and 500 mg) versus methotrexate in terms of safety and tolerability<br>4. To assess Quality of Life of patients treated with ZD1839 (250 mg and 500 mg) versus methotrexate<br>;Primary end point(s): Patients will receive one dose of ZD1839 daily until disease progression or discontinuation from the study for any other reason (see section 3.3.5 of protocol). All patients will be followed for survival.