Clinical trial · Interventional
Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)
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
NCT00206219CI-TRIAL-00004360completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer in terms of overall survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Compare ZD1839 versus methotrexate in overall survival
Secondary outcomes (1)
- measure
- Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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.
References
Publications (0)
Data not yet available
No reference posted for this study.