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

NCT ID: NCT00454142

Last Updated: 2015-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (pazopanib hydrochloride)

Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Pharmacological study will be done on Day 1 and Day 28. Computed tomography will be done at baseline and day 28.

Group Type: EXPERIMENTAL

pazopanib hydrochloride

Intervention Type: DRUG

Given PO

pharmacological study

Intervention Type: OTHER

Correlative studies

computed tomography

Intervention Type: PROCEDURE

Correlative studies

Interventions

pazopanib hydrochloride

Given PO

Intervention Type: DRUG

pharmacological study

Correlative studies

Intervention Type: OTHER

computed tomography

Correlative studies

Intervention Type: PROCEDURE

Other Intervention Names

GW786034B; Votrient; pharmacological studies; tomography, computed

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed nasopharyngeal carcinoma, meeting the following criteria:

• World Health Organization (WHO) type II-III disease
• Stage IV or recurrent disease
• Must have failed at least 1 prior line of chemotherapy for metastatic or recurrent disease
• Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
• No known brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 70-100%
• Life expectancy > 3 months
• WBC >= 3,000/mm³
• Absolute neutrophil count >= 1,500/mm³
• Platelet count >= 100,000/mm³
• Bilirubin normal
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal (ULN)
• Creatinine normal OR creatinine clearance >= 60 mL/min
• Proteinuria =< 1+ on 2 consecutive dipsticks taken >= 1 week apart
• Prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.2 times ULN
• Systolic blood pressure (BP) =< 140 mm Hg and diastolic BP =< 90 mm Hg

• Initiation or adjustment of BP medication allowed provided the average of 3 BP readings are < 140/90 mm Hg prior to study entry
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or to other study agents
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• No cerebrovascular accident within the past 6 months
• No history of any of the following diseases within the past 12 weeks:

• Myocardial infarction
• Cardiac arrhythmia
• Admission for unstable angina
• Cardiac angioplasty or stenting
• Venous thrombosis
• No New York Heart Association (NYHA) class III-IV heart failure

• Patients with a history of NYHA class II heart failure are eligible provided they are asymptomatic on treatment
• No significant electrocardiogram (ECG) abnormalities, including QTc prolongation (i.e., QTc >= 500 msec)
• No serious or non-healing wound, ulcer, or bone fracture
• No condition that would impair the ability to swallow and retain pazopanib hydrochloride, including any of the following:

• Gastrointestinal tract disease resulting in an inability to take oral medication
• Requirement for IV alimentation
• Prior surgical procedures affecting absorption
• Active peptic ulcer disease
• No concurrent uncontrolled illness including, but not limited to, the following:

• Coagulopathy
• Ongoing or active infection
• Psychiatric illness or social situation that would preclude study compliance
• No known allergy to CT contrast agents
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
• More than 4 weeks since prior radiotherapy
• At least 4 weeks since prior surgery
• No prior antiangiogenesis therapy
• No other concurrent investigational agents
• No other concurrent anticancer therapy
• No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of pazopanib hydrochloride, as determined by the Principal Investigator
• No concurrent medications that have the potential to interact with the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4
• No concurrent therapeutic warfarin

• Low molecular weight heparin or prophylactic low-dose warfarin allowed
• No concurrent antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wan Teck Lim

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre

Locations

Cancer Therapeutics Research Group

Singapore, , Singapore

National University Hospital

Singapore, , Singapore

National Cancer Centre

Singapore, , Singapore

Countries

Singapore

Other Identifiers

NCI-2009-00197

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000537520

Identifier Type: REGISTRY

Identifier Source: secondary_id

CTRG-NP05/25/06

Identifier Type: OTHER

Identifier Source: secondary_id

NCC-06-01

Identifier Type: OTHER

Identifier Source: secondary_id

7623

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2009-00197

Identifier Type: -

Identifier Source: org_study_id