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

Non Small Cell Lung Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252798
• Other study ID #: D7913C00073
• Secondary ID: 1839IL/0073
• Status: Completed
• Phase: Phase 1
• First received: November 1, 2005
• Last updated: December 16, 2007
• Start date: July 2002
• Est. completion date: October 2005

Study information

• Verified date: December 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Carcinoma

Intervention

Drug:
• Gefitinib

• Carboplatin

• Paclitaxel

Procedure:
• Radiation

Locations

Country	Name	City	State
Australia	Research Site	East Melbourne	Victoria
Australia	Research Site	Woolloonabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Australia, 

Outcome

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