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

AstraZeneca1 site in 1 country44 target enrollmentJuly 2002

ConditionsNon Small Cell Lung Carcinoma

DrugsGefitinib Carboplatin Paclitaxel

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Non Small Cell Lung Carcinoma
Sponsor: AstraZeneca
Enrollment: 44
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2002

End Date

October 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

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)