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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00252798

Purpose

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.

Condition	Intervention	Phase
Non Small Cell Lung Carcinoma	Drug: Gefitinib Drug: Carboplatin Drug: Paclitaxel Procedure: Radiation	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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)

Estimated Enrollment:	44
Study Start Date:	July 2002
Study Completion Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252798

Locations

Australia, Queensland
Research Site
Woolloonabba, Queensland, Australia
Australia, Victoria
Research Site
East Melbourne, Victoria, Australia

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Australia Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	D7913C00073, 1839IL/0073
Study First Received:	November 1, 2005
Last Updated:	December 16, 2007
ClinicalTrials.gov Identifier:	NCT00252798
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AstraZeneca:

Non Small Cell Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases

Carboplatin
Gefitinib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009