CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,690 enrolled
Drug / intervention
Docetaxel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00312377
NCT00312377Phase 3Completed

A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC

Genzyme, a Sanofi Company·interventional·Posted Apr 10, 2006·Updated Sep 30, 2016

In Brief

A Phase 3 clinical trial evaluating Docetaxel and Vandetanib for Non-small Cell Lung Cancer and Lung Cancer. Completed, enrolled 1,690 participants across 156 sites in 25 countries.

Detailed Summary

This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy. This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone. All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer. In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent. Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients. Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, India, Indonesia, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, Singapore, South Korea, Spain, Thailand, Turkey (Türkiye), United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 10, 2006
Enrollment StartMay 1, 2006
Primary CompletionAug 1, 2008
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.2 years ago

Interventions

Docetaxeldrug

infusion

Vandetanibdrug

oral