Clinical trial · Interventional
Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer
A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate Cancer
NCT00239291CI-TRIAL-00002233completedPhase 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)
To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer
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 |
|---|---|---|---|
| Non-Metastatic Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib, radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Part A: Safety (incidence of DLTs)
- measure
- Part B: Tolerability
Secondary outcomes (1)
- measure
- EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer * PSA below 20 ng/mL * Lymph node negative * Non-metastatic * Written informed consent Exclusion Criteria: * Well differentiated stage T2 prostate cancer (Gleason score 2 to 4) * Distant or nodal metastases * Prostatectomy * Concomitant LHRH analog treatment * Previous or concomitant anti-androgens * Active ILD
References
Publications (0)
Data not yet available
No reference posted for this study.