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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00252798

Enrollment

Registered

2005-11-15

Start date

2002-07-31

Completion date

2005-10-31

Last updated

2007-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Carcinoma

Keywords

Non Small Cell Lung Cancer

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.

Interventions

DRUGGefitinib

DRUGCarboplatin

DRUGPaclitaxel

PROCEDURERadiation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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 evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy	—
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)	—
To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026