NCT01414426

Vandetanib in Preventing Head and Neck Cancer in Patients With Precancerous Head and Neck Lesions

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Lip and Oral Cavity Squamous Cell Carcinoma
• Oral Cavity Verrucous Carcinoma
• Precancerous Condition

Interventions

Type	Name	Description
DRUG	vandetanib	Given PO
OTHER	placebo	Given PO
OTHER	immunohistochemistry staining method	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
PROCEDURE	biopsy	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2012-01-01
• Primary completion: 2019-01-01
• Completion: 2019-06-01
• First posted: 2011-08-11
• Last updated: 2021-01-14
• Results posted: 2021-01-14

Locations

1 site across 1 country: United States