Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer
|Recurrent Uterine Corpus Sarcoma Uterine Carcinosarcoma||Drug: Pazopanib Hydrochloride||Phase 2|
|Study Design:||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|
- 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.
- 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.
|Study Start Date:||January 2011|
|Study Completion Date:||January 2016|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (pazopanib hydrochloride)
Patients receive pazopanib hydrochloride PO QD 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 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247571
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|Principal Investigator:||Susana Campos||NRG Oncology|