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

Condition(s) targeted: Non-Small Cell Lung Cancer; Lung Cancer

Intervention: Docetaxel (Drug); Vandetanib (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Zactima Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

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

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

Primary outcome: The improvement in progression-free survival time for the vandetanib and docetaxel combination over docetaxel alone

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

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AstraZeneca Clinical Trial Information - Outside US

Starting date: March 2006
Ending date: July 2008
Last updated: June 12, 2008