Clinical trial · Interventional
ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
NCT00252798CI-TRIAL-00001034completedPhase 1ClinicalTrials.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 primary objective of the trial is to determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.
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 Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Gefitinib | Drug | Gefitinib | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Radiation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.
Secondary outcomes (8)
- measure
- To evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy
- measure
- Estimating the objective response rate (complete response [CR] & partial response [PR]) as assessed by positron emission tomography with (18F)-labelled fluorodeoxyglucose (PET-FDG)
- measure
- To estimate the objective response rate (CR and PR) as assessed by computerised tomography (CT) scan
- measure
- To estimate the complete response rate (CR) as assessed by PET-FDG
- measure
- To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically or cytologically confirmed locally advanced stage IIIA or IIIB NSCLC (without pleural effusion) * Patients with apical tumours and supraclavicular nodes are acceptable if both can be easily encompassed in one radiation field * Minimum life expectancy with treatment of 6 months * WHO performance status 0-1 Exclusion Criteria: * Patients with previous malignancies other than NSCLC * Previous radiotherapy for NSCLC * Previous immunotherapy or chemotherapy * Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy * Forced expiratory volume in 1 second (FEV1) less than 1 litre (L) * Absolute neutrophil count (ANC) less than 1.5 x 109/L or platelets less than 100 x 109/L * Serum bilirubin greater than 1.25 times the upper limit of reference range * ALT or AST greater than 2.5 times the ULRR
References
Publications (0)
Data not yet available
No reference posted for this study.