Pazopanib in Treating Patients With Stage IV or Recurrent Nasopharyngeal Cancer
RATIONALE: Pazopanib 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.
PURPOSE: This phase II trial is studying the side effects and how well pazopanib works in treating patients with stage IV or recurrent nasopharyngeal cancer.
Head and Neck Cancer
Drug: pazopanib hydrochloride
Other: pharmacological study
Procedure: computed tomography
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of GW786034 (Pazopanib) in Asian Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma|
- Clinical benefit rate as defined by RECIST criteria (complete response, partial response, or stable disease) [ Designated as safety issue: No ]
- Response rate (complete and partial response) [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Study Completion Date:||December 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
- Determine the efficacy of pazopanib hydrochloride in patients with stage IV or recurrent nasopharyngeal carcinoma.
- Determine the progression-free survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Determine the effect of this drug on angiogenesis inhibition using dynamic contrast-enhanced CT scan.
- Determine the pharmacokinetic profile of this drug in these patients.
- Correlate the effect of this drug on angiogenesis inhibition with the clinical benefit rate and pharmacokinetics.
OUTLINE: Patients receive oral pazopanib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically during study treatment for pharmacokinetic studies. Patients also undergo dynamic contrast-enhanced (DCE) CT scan at baseline and on days 2 and 29 to document the antiangiogenic effect of pazopanib hydrochloride and explore the use of DCE CT scan as a surrogate marker of response.
After completion of study treatment, patients are followed periodically for up to 12 months.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
|Cancer Institute at National University Hospital|
|Singapore, Singapore, 119074|
|National Cancer Centre - Singapore|
|Singapore, Singapore, 169610|
|Study Chair:||Darren L. Wan Teck, MD||National Cancer Centre, Singapore|