Clinical trial · Interventional
Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer
Phase I-II Study of ZD1839 (IRESSA®), Cisplatin, and External-Beam Radiation Therapy in Patients With Locally Advanced, Non-Metastatic, Squamous Cell Carcinoma of the Head and Neck
NCT00195078CI-TRIAL-00000797terminatedPhase 1 / Phase 2ClinicalTrials.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)
The purpose of this study is to find out whether adding ZD1839 to standard treatment (Cisplatin and Radiation Therapy) of unresectable head and neck cancers is better than cisplatin and radiation alone.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To explore whether the addition of ZD1839 to standard treatment of unresectable head and neck cancers (i.e., cisplatin and radiation therapy) improves the clinical complete response rate (as measured by RECIST criteria).
Secondary outcomes (3)
- measure
- To determine the time to disease progression, duration of response, and 2?year disease-free survival in subjects with unresectable tumors of the head and neck after combined therapy with ZD1839, cisplatin, and radiation.
- measure
- To determine the toxicities, and recovery from toxicities, of combined therapy with ZD1839, cisplatin, and radiation therapy.
- measure
- To determine dose-limiting toxicity as well as the recommended Phase II dose of ZD1839 given concurrently with cisplatin and radiation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. For the Phase II portion of the study: measurable disease as based on RECIST criteria. * Stage III or IV disease, M0. * Life expectancy \> 6 months. Exclusion Criteria: * Known severe hypersensitivity to ZD1839 or any of the excipients of this product. * Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of squamous cell carcinoma of the skin or cervical cancer in situ. * Previous treatment with radiation, chemotherapy, or definitive surgical therapy. * Distant metastatic disease. * Documented evidence of HIV infection (because the interaction of ZD1839 with Highly Active Anti-Retroviral Therapy \[HAART\] is unknown). * Substance abuse or psychiatric problems that would interfere with compliance. * Pregnancy or breast-feeding (women of child-bearing potential). * Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment. * Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
References
Publications (0)
Data not yet available
No reference posted for this study.