Clinical Trial: Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma

Brief Summary: This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced angiosarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the progression free survival (PFS) at 3 months and response rate defined as complete response (CR) and partial response (PR) in angiosarcoma patients treated with pazopanib.

SECONDARY OBJECTIVES:

I. To assess overall survival of patients treated with pazopanib. II. To gather more safety data for pazopanib in this patient population. III. To explore the ability of [F-18] fludeoxyglucose (FDG) (positron emission tomography [PET])/computed tomography (CT) imaging to assess response.

OUTLINE:

Patients receive pazopanib hydrochloride orally (PO) once daily (QD). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.


Sponsor: Fox Chase Cancer Center

Current Primary Outcome: PFS [ Time Frame: 3 months ]

Estimated using the method of Kaplan and Meier.


Original Primary Outcome: Response Rate [ Time Frame: at 3 months ]

Using a Simon design with n1=15, n2=30, we will submit 15 patients initially and evaluate them for response and any time up to 3 months. If at least 1/15 patient responds, then another 15 patients will be recruited. If at least 4/30 patients respond the investigators will reject the null of 5% response and accept the 20% alternative. Otherwise, the study will be terminated after the initial 15 patients are evaluated and the null hypothesis accepted. The study has 46% chance of early stopping under the null, 3.5% under the alternative. It has overall 86% power and 5.8% type I error.


Current Secondary Outcome:

  • Response rate defined as CR and PR in angiosarcoma patients treated with pazopanib hydrochloride [ Time Frame: 3 months ]
    Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.
  • Overall survival of patients treated with pazopanib hydrochloride [ Time Frame: Up to 2 years ]
    Estimated using the method of Kaplan and Meier.
  • Evaluation of toxicity and safety for pazopanib hydrochloride in this patient population [ Time Frame: Up to 2 years ]
  • [F-18] FDG PET/CT as an imaging agent in predicting efficacy or early response as compared with CT imaging [ Time Frame: Up to 2 years ]
    Descriptive statistics will include mean, SD, median, minimum, and maximum for continuous variables and the numbers and percentages for categorical variables. Summary statistics for changes in SUVs, tumor to background ratios, lesion size, and comparison scores will be analyzed and presented.


Original Secondary Outcome: Progression Free Survival [ Time Frame: at 3 months ]

Using a Simon design with n1=15, n2=30, we will submit 15 patients initially and evaluate them for response and any time up to 3 months. If at least 1/15 patient responds, then another 15 patients will be recruited. If at least 4/30 patients respond the investigators will reject the null of 5% response and accept the 20% alternative. Otherwise, the study will be terminated after the initial 15 patients are evaluated and the null hypothesis accepted. The study has 46% chance of early stopping under the null, 3.5% under the alternative. It has overall 86% power and 5.8% type I error.


Information By: Fox Chase Cancer Center

Dates:
Date Received: October 27, 2011
Date Started: November 3, 2011
Date Completion: December 15, 2020
Last Updated: January 24, 2017
Last Verified: January 2017