Iressa Versus Docetaxel (Taxotere)

• ClinicalTrials.gov Identifier: NCT00076388
• Recruitment Status: Completed
• First Posted: January 23, 2004
• Last Update Posted: May 13, 2011
• Sponsor: AstraZeneca
• Information provided by: AstraZeneca

Tracking Information

• First Submitted Date: January 21, 2004
• First Posted Date: January 23, 2004
• Last Update Posted Date: May 13, 2011
• Study Start Date: February 2004
• Actual Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 28, 2005): To compare overall survival between ZD1839 and docetaxel
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: September 28, 2005)

• 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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Small-Cell Lung Carcinoma

Intervention

• Drug: Gefitinib
• Drug: Docetaxel

• Study Arms: Not Provided

Publications *

• Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.
• 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. doi: 10.1200/JCO.2009.24.3030. 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. doi: 10.1016/S0140-6736(08)61758-4.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 28, 2005): 1440
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 2007
• Actual Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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, United States

Administrative Information

• NCT Number: NCT00076388
• Other Study ID Numbers: D791GC00001; EudraCT No: 2004-002943-28; 1839IL/0721
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: AstraZeneca
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: AstraZeneca Iressa Medical Science Director, MD; AstraZeneca

• PRS Account: AstraZeneca
• Verification Date: May 2011