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

Phase 1

Completed

• Conditions: Non Small Cell Lung Carcinoma

• Registration Number: NCT00252798
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study Completion: 2005-10
• Study First Submitted: 2005-11-01
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-15
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-16
• Last Update Posted: 2007-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Research Site; 🇦🇺 East Melbourne, Victoria, Australia