Head and Neck Phase III Iressa Vs Methotrexate Refractory. Iressa Vs Methotrexate (IMEX)

Purpose- This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer in terms of overall survival.

Official Title

A Phase III Randomised, Stratified, Parallel-Group, Mulit-Centre, Comparative Study of ZD1839 (Iressa) 250 mg and 500 mg Versus Methotraxate for Previously Treated Patients with Squamous Cell Carcinoma of the Head and Neck

Conditions

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcomes: Compare ZD1839 versus methotrexate in overall survivalSecondary Outcomes: Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life – assessed throughout the study.

Study Start

November 2003

Eligibility & Criteria

Ages Eligible for Study: 18 Years and aboveGenders Eligible for Study: Both CriteriaInclusion Criteria:- Histological confirmation of evidence of squamous cell carcinoma of the head and neck. – Tumors have progressed after primary treatment with radiation or chemoradiation and have failed to respond to at least one course of standard platinum-based chemotherapy. – Tumors have progressed after primary treatment with radiation or chemoradiation and are considered unsuitable for platinum-based chemotherapy. Exclusion Criteria:- Carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumors. – Isolated recurrent disease that may be amenable to local therapy; e.g., surgical intervention or radiation therapy. – Known severe hypersensitivity to ZD1839, Methotrexate or any of the excipients of these products.

Total Enrolment

477

Contact Details

Australia, New South WalesResearch Site, Westmead, New South Wales, Australia; Recruiting