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: None (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: CT scan or MRI if used to follow lesion(s) for measurable disease every other cycle for the first 6 mnths; then every 3 mnths thereafter until dx progression is confirmed; also repeat any other time clinically indicated, assessed up to 6 months. ]Complete and Partial Tumor Response by RECIST 1.0. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- Percentage of Participants With Progression-free Survival (PFS) at 6 Months [ Time Frame: 6 months ]Progression-free survival is the period from study entry until disease progression, death or date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20 % increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Number of Patients With Grade 3 or Higher Adverse Events [ Time Frame: Every cycle while on treatment ]Grade 3 or higher adverse events were graded by CTCAE v4.
- Progression-free Survival [ Time Frame: From start of treatment to time of progression or death, assessed up to 5 years ]Progression-free survival is the period from study entry until disease progression, death or date of last contact
- Overall Survival [ Time Frame: Time from start of treatment to time of death or the date of last contact, assessed up to 5 years ]The observed length of life from entry into the study to death or the date of last contact.
|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|