NCT00454142

Pazopanib Hydrochloride in Treating Patients With Stage IV or Recurrent Nasopharyngeal Cancer

A Phase 2 Study of GW786034 (Pazopanib) in Asian Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well pazopanib hydrochloride works in treating patients with stage IV or recurrent nasopharyngeal cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVES: I. Determine the efficacy of pazopanib hydrochloride in patients with stage IV or recurrent nasopharyngeal carcinoma. II. Determine the progression-free survival of patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine the effect of this drug on angiogenesis inhibition using dynamic contrast-enhanced computed tomography (CT) scan. V. Determine the pharmacokinetic profile of this drug in these patients. VI. Correlate the effect of this drug on angiogenesis inhibition with the clinical benefit rate and pharmacokinetics. OUTLINE: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 12 months.

Conditions

• Recurrent Lymphoepithelioma of the Nasopharynx
• Recurrent Squamous Cell Carcinoma of the Nasopharynx
• Stage IV Lymphoepithelioma of the Nasopharynx
• Stage IV Squamous Cell Carcinoma of the Nasopharynx

Interventions

Type	Name	Description
DRUG	pazopanib hydrochloride	Given PO
OTHER	pharmacological study	Correlative studies
PROCEDURE	computed tomography	Correlative studies

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-04-01
• Completion: 2010-08-01
• First posted: 2007-03-30
• Last updated: 2015-12-17
• Results posted: 2015-12-17

Locations

3 sites across 1 country: Singapore