Clinical Trial: Vandetanib in Preventing Head and Neck Cancer in Patients With Precancerous Head and Neck Lesions

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Placebo- Controlled Pilot Study of ZD6474 as a Chemopreventive Agent for Premalignant Lesions of the Head and Neck

Brief Summary: This randomized phase II trial studies how well vandetanib works in preventing head and neck cancer in patients with precancerous head and neck lesions. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vandetanib may keep cancer from forming in patients with premalignant lesions

Detailed Summary:

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.


Sponsor: University of Chicago

Current Primary Outcome: Comparison between treatment groups of the within-patient change in MVD score following treatment initiation [ Time Frame: Baseline to 3 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse events rate [ Time Frame: Weekly during treatment and at 6, 9, and 12 months ]
  • Adherence to treatment [ Time Frame: Over 6 months ]
  • Development of oral and other cancers [ Time Frame: At 6, 9, and 12 months and then ever 6 months for 2 years ]
  • Biologic effect of EGFR and VEGFR2 inhibition [ Time Frame: Baseline and 3 and 6 months ]


Original Secondary Outcome: Same as current

Information By: University of Chicago

Dates:
Date Received: August 9, 2011
Date Started: January 2012
Date Completion: December 2017
Last Updated: May 10, 2017
Last Verified: May 2017