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

AstraZeneca44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Small Cell Lung Carcinoma

Interventions

GefitinibDRUG

CarboplatinDRUG

PaclitaxelDRUG

RadiationPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Woolloonabba, Queensland, Australia

Research Site

East Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

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

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)

Data from ClinicalTrials.gov

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