Iressa Versus Docetaxel (Taxotere) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 21, 2004

Last Updated Date

January 15, 2009

Start Date ^†

February 2004

Current Primary Outcome Measures ^†

To compare overall survival between ZD1839 and docetaxel

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00076388 on ClinicalTrials.gov Archive Site

Current 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

Original 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

Descriptive Information

Brief Title ^†

Iressa Versus Docetaxel (Taxotere)

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Non-Small-Cell Lung Carcinoma

Intervention ^†

Drug: Gefitinib
Drug: Docetaxel

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

1440

Completion Date

Primary Completion Date

Eligibility 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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Argentina, Belgium, Brazil, Canada, China, Croatia, Denmark, Estonia, France, Germany, Hong Kong, Indonesia, Italy, Latvia, Malaysia, Mexico, Philippines, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00076388

Responsible Party

Secondary IDs ^††

EudraCT No: 2004-002943-28, D791GC00001

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Investigators ^†

Study Director:

AstraZeneca Iressa Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.