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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00312377

Purpose

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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer Lung Cancer	Drug: Docetaxel Drug: Vandetanib	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Vandetanib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1240
Study Start Date:	March 2006
Estimated Study Completion Date:	August 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Docetaxel monotherapy	Drug: Docetaxel oral
2: Experimental Vandetanib + Docetaxel	Drug: Docetaxel oral Drug: Vandetanib oral

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312377

Show 167 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Zactima Medical Science Director, MD

AstraZeneca

More Information

Additional Information:

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

US and Canda Only This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D4200C00032, 6474IL/0032
Study First Received:	April 6, 2006
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00312377 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Non-small cell lung cancer
NSCLC

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 22, 2009