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

Completed · Phase 3

Conditions studied: Non-small Cell Lung Cancer, Lung Cancer

In brief

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.

Key facts

Study ID

NCT00312377

Run by

Genzyme, a Sanofi Company

People needed

1690

Starts

2006-05-01

Expected to finish

2014-03-01

Last updated by the study team

2016-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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-tyrosine kinase inhibitors (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.

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Northridge, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Norwalk, Connecticut, United States
• Research Site — Ocala, Florida, United States
• Research Site — Marietta, Georgia, United States
• Research Site — Joliet, Illinois, United States
• Research Site — Park Ridge, Illinois, United States
• Research Site — Hutchinson, Kansas, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Henderson, Nevada, United States
• Research Site — Albany, New York, United States
• Research Site — Armonk, New York, United States
• Research Site — New York, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Hickory, North Carolina, United States
• Research Site — Portland, Oregon, United States
• Research Site — Austin, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Ogden, Utah, United States
• Research Site — Alexandria, Virginia, United States
• Research Site — Fullerton, California, United States

Full record on ClinicalTrials.gov

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