ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-Small Cell Lung Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

April 6, 2006

Last Updated Date

April 3, 2009

Start Date ^ICMJE

March 2006

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The improvement in progression-free survival time for the vandetanib and docetaxel combination over docetaxel alone [ Time Frame: Treatment until death ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Demonstrate an improvement in progression-free survival for ZACTIMA™ in combination with docetaxel over docetaxel alone in 2nd line NSCLC subjects

Change History

Complete list of historical versions of study NCT00312377 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Demonstrate an improvement of overall survival for ZACTIMA™ in combination with docetaxel over docetaxel alone [ Time Frame: Treatment until death ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Demonstrate an improvement of overall survival for ZACTIMA™ in combination with docetaxel over docetaxel alone

Descriptive Information

Brief Title ^ICMJE

ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-Small Cell Lung Cancer

Official Title ^ICMJE

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

Brief 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-VEGFR properties) and the tumour cells themselves (through it's anti-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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Non-Small Cell Lung Cancer
Lung Cancer

Intervention ^ICMJE

Drug: Docetaxel
Drug: Vandetanib

Study Arms / Comparison Groups

Active Comparator: Docetaxel monotherapy
Experimental: Vandetanib + Docetaxel

Publications *

* 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 ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1240

Estimated Completion Date

August 2009

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Lung cancer patients who answer true to the following statements are eligible to join this clinical study.

I have a confirmed diagnosis of locally advanced or metastatic non small cell lung cancer (Stage IIIb - IV)
I have had 1st line anti-cancer therapy. Previous treatment with Avastin (bevacizumab) in first line NSCLC is allowed.

Exclusion Criteria:

Lung cancer patients who answer true to the following are NOT eligible to join this clinical study.

I do not have non small cell lung cancer (NSCLC)
I have received treatment with docetaxel (Taxotere). Prior treatment with paclitaxel is acceptable.
I have received 2nd line anti-cancer therapy (For example, patients with previous 2nd line non small cell lung cancer (NSCLC) treatment with Tarceva (erlotinib, OSI-744), Alimta (pemetrexed) are not eligible)
I have been treated with VEGFR-TKIs (sunitinib, sorafenib, other VEGF TKIs). Previous treatment with Avastin (bevacizumab) in 1st line non small cell lung cancer is permitted.
I have a history of uncontrolled irregular heartbeat
I have a history of high blood pressure which has not been controlled with medication

If you are unsure of the meaning of the inclusion and exclusion criteria above, please contact the call center number for help.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, India, Indonesia, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Portugal, Singapore, Spain, Thailand, Turkey, Vietnam

Administrative Information

NCT ID ^ICMJE

NCT00312377

Responsible Party

Study ID Numbers ^ICMJE

D4200C00032, 6474IL/0032

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Zactima Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP