ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer

Conditions
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Non Small Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Gefitinib
* Drug: Carboplatin
* Drug: Paclitaxel
* Procedure: Radiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|nan|
|Drug: Carboplatin|nan|
|Drug: Paclitaxel|nan|
|Procedure: Radiation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy |  |  | 
| Estimating the objective response rate (complete response [CR] & partial response [PR]) as assessed by positron emission tomography with (18F)-labelled fluorodeoxyglucose (PET-FDG) |  |  | 
| To estimate the objective response rate (CR and PR) as assessed by computerised tomography (CT) scan |  |  | 
| To estimate the complete response rate (CR) as assessed by PET-FDG |  |  | 
| To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG |  |  | 
| To estimate overall survival |  |  | 
| To characterise the safety and tolerability of ZD1839 combined with concurrent carboplatin, paclitaxel and radiation |  |  | 
| To determine the site of first failure (characterised as local-regional, distant or both) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung Cancer