Randomized Placebo- Controlled Pilot Study of ZD6474 as a Chemopreventive Agent for Premalignant Lesions of the Head and Neck
PRIMARY OBJECTIVE:
I. Determine the effect of ZD6474 (vandetanib) compared to placebo on microvessel density
(MVD) from baseline to 3 months in patients at risk for oral squamous cell carcinoma (OSCC)
with preneoplastic lesions.
SECONDARY OBJECTIVES:
I. Change in MVD over 6 months. II. Change in putative targets of ZD6474: tissues will be
analyzed by immunohistochemistry (IHC) for phosphorylated epidermal growth factor receptor
(pEGFR), EGFR, phosphorylated-vascular endothelial growth factor receptor 2 (pVEGFR2),
VEGFR2.
III. Change in proliferative index as measured by Ki-67 IHC. IV. Safety, tolerability, and
adherence to ZD6474 for 6 months in patients at risk for OSCC.
TERTIARY OBJECTIVES:
I. Compare OSCC incidence in both study arms (ZD6474 and placebo).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive vandetanib orally (PO) once daily (QD) for 6 months. Treatment
continues in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD for 6 months. Treatment continues in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 9 and 12 months and then
every 6 months for 2 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Comparison between treatment groups of the within-patient change in MVD score following treatment initiation
A Wilcoxon ranksum test may be used if the normality assumption is not satisfied. Alternatively, change in MVD may be transformed (e.g. log-transformation) to satisfy the normality assumption. Additional analyses will include linear regression models with treatment effect and other prognostic factors as covariates.
Baseline to 3 months
No
Ezra Cohen
Principal Investigator
University of Chicago
United States: Food and Drug Administration
11-0265
NCT01414426
January 2012
January 2014
Name | Location |
---|---|
University of Chicago | Chicago, Illinois 60637 |