Clinical Trial: Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Evaluation of Pazopanib (NSC # 737754) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Brief Summary: This phase II trial studies how well pazopanib hydrochloride works in treating patients with uterine cancer that has come back or has not responded to treatment. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of uterine cancer by blocking blood flow to the tumor.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess the activity of pazopanib in patients with persistent or recurrent carcinosarcoma of the uterus as measured by the proportion of patients who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial).

SECONDARY OBJECTIVES:

I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria of Adverse Events version 4.0 (CTCAE v4.0).

II. To determine the duration of progression-free survival and overall survival.

OUTLINE: This is a multicenter study.

Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 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 and then every 6 months for 3 years.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Objective tumor response (complete or partial) [ Time Frame: Up to 5 years ]
  • Progression-free survival (PFS) for at least 6 months [ Time Frame: 6 months ]
    Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.


Original Primary Outcome:

  • Progression-free survival (PFS) for at least 6 months
  • Objective tumor response (complete or partial)


Current Secondary Outcome:

  • Incidence of adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 5 years ]
    The numbers of patients with toxicities as assessed by CTCAE v4 will be tabulated by grade and system organ class.
  • Overall survival [ Time Frame: Time from start of treatment to time of death or the date of last contact, assessed up to 5 years ]
    Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
  • PFS [ Time Frame: From start of treatment to time of progression or death, assessed up to 5 years ]
    Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.


Original Secondary Outcome:

  • Adverse events as assessed by CTCAE v4.0
  • PFS and overall survival


Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 23, 2010
Date Started: January 2011
Date Completion:
Last Updated: May 6, 2016
Last Verified: May 2016