Iressa Versus Docetaxel (Taxotere) - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00076388

Purpose

The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.

Condition	Intervention	Phase
Non-Small-Cell Lung Carcinoma	Drug: Gefitinib Drug: Docetaxel	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Gefitinib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare overall survival between ZD1839 and docetaxel

Secondary Outcome Measures:

To compare time to progression (TTP) between ZD1839 and docetaxel
To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel
To compare the overall objective tumor response rate between ZD1839 and docetaxel
To compare patient-reported functionality (PRF) and quality of life (QoL) between ZD1839 and docetaxel
To compare safety and tolerability of ZD1839 and docetaxel

Estimated Enrollment:	1440
Study Start Date:	February 2004
Study Completion Date:	October 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously irradiated or non measurable disease
Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
WHO performance status (PS) 0-2
Absolute Neutrophil Count (ANC) >1.5 x 109/liter (L) and platelets >100 x 109/L
Life expectancy of at least 8 weeks

Exclusion Criteria:

Prior ZD1839 therapy
Prior docetaxel treatment for NSCLC
Less than 14 days since completion of prior radiotherapy
Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
Evidence of clinically active Interstitial Lung Disease
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days
Patients with pre existing peripheral neuropathy >= grade 2 (NCI CTC criteria)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076388

Show 162 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Iressa Medical Science Director, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, Liao ML, Bischoff H, Reck M, Sellers MV, Watkins CL, Speake G, Armour AA, Kim ES. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol. 2010 Feb 10;28(5):744-52. Epub 2009 Dec 28.

Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008 Nov 22;372(9652):1809-18.

ClinicalTrials.gov Identifier:	NCT00076388 History of Changes
Other Study ID Numbers:	D791GC00001, EudraCT No: 2004-002943-28, 1839IL/0721
Study First Received:	January 21, 2004
Last Updated:	May 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Non-Small-Cell Lung Cancer

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Lung Diseases
Respiratory Tract Diseases
Docetaxel
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012