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

NCT ID: NCT00252798

Last Updated: 2007-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2005-10-31

Brief Summary

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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

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Conditions

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Non Small Cell Lung Carcinoma

Keywords

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gefitinib

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Paclitaxel

Intervention Type DRUG

Radiation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Australia Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Woolloonabba, Queensland, Australia

Site Status

Research Site

East Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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1839IL/0073

Identifier Type: -

Identifier Source: secondary_id

D7913C00073

Identifier Type: -

Identifier Source: org_study_id