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

NCT00454142 | Completed Phase 2 Results

• 5 other identifiers: NCI-2009-00197CDR0000537520CTRG-NP05/25/06NCC-06-017623
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit Rate

  Clinical benefit rate (CBR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST ver 1.0) and assessed by CT or MRI. CBR includes 1) Complete response (CR): disappearance of all lesions; 2) partial response (PR): \>=30% decrease in the sum of the longest diameter of target lesions and 3) stable disease (SD): non-PR and non progressive disease.

  12 weeks of treatment

Secondary Outcomes (11)

• Response Rate (PR)

  12 weeks of treatment

• Progression-free Survival

  From the date of enrollment to the date of first documented progression or death, whichever occurs first, or to the date when the patient was last known to be alive, up to 3 years.

• Overall Survival

  From date of enrollment to the study to the date of death from any cause or to the date when the patient was last known to be alive, up to 3 years.

• Toxicity Profile: Percentage of Participants With Significant (Grade 3/4) Related Adverse Event (AE)

  From the time of first treatment with pazopanib hydrochloride to up to 30days after completion of treatment

• Pharmacodynamic Study: Tumor Blood Flow at Baseline

  Pretreatment

Study Arms (1)

Treatment (pazopanib hydrochloride)

EXPERIMENTAL

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.

Drug: pazopanib hydrochloride; Other: pharmacological study; Procedure: computed tomography

Interventions

pazopanib hydrochloride DRUG

Given PO

Also known as: GW786034B, Votrient

Treatment (pazopanib hydrochloride)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (pazopanib hydrochloride)

computed tomography PROCEDURE

Correlative studies

Also known as: tomography, computed

Treatment (pazopanib hydrochloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Cancer Therapeutics Research Group

Singapore, 119074, Singapore

Location

National University Hospital

Singapore, 119074, Singapore

Location

National Cancer Centre

Singapore, 169610, Singapore

Location

MeSH Terms

Interventions

pazopanib

Results Point of Contact

• Title: Dr. Wan Teck LIM
• Organization: National Cancer Centre Singapore

dmolwt@nccs.com.sg

65-64368174

Study Officials

• Wan Teck Lim

  National Cancer Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 30, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 17, 2015
• Results First Posted: December 17, 2015

Record last verified: 2012-01

Locations

SG (3)