Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer
This phase II clinical trial is studying how well pazopanib hydrochloride works in treating patients with recurrent or persistent uterine cancer. 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.
Recurrent Uterine Sarcoma
Drug: pazopanib hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Pazopanib (NSC # 737754) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus|
- Progression-free survival (PFS) for at least 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
- Objective tumor response (complete or partial) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]The numbers of patients with toxicities as assessed by CTCAE v4 will be tabulated by grade and system organ class.
- PFS and overall survival [ Time Frame: From start of treatment to time of progression or death, assessed up to 5 years ] [ Designated as safety issue: No ]Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (pazopanib hydrochloride)
Patients receive pazopanib hydrochloride PO once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: pazopanib hydrochloride
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).
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247571
Show 41 Study Locations
|Principal Investigator:||Susana Campos||Gynecologic Oncology Group|