A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer

Status:	Active, not recruiting
Conditions:	Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	10/25/2018
Start Date:	September 2012
End Date:	December 31, 2018

A Randomized Open Label Phase II Study of Weekly Gemcitabine Plus Pazopanib Versus Weekly Gemcitabine Alone in the Treatment of Patients With Persistent or Relapsed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common
cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian
cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients
with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib
is a novel agent has recently been approved for the treatment of subjects with advanced renal
cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers
such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and
safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for
recurrent or persistent ovarian cancer. This is an open label study in which subjects will be
randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib.
Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle.
Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All
subjects will be monitored for toxicity and other indicators of safety (labs, physical exams,
vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5
years following the conclusion of treatment to evaluate efficacy. The primary endpoints of
the study are progression free survival and overall survival, which will be assessed at three
years.

Inclusion Criteria:

- Must be at least 18 years old

- Must have measurable or detectable ovarian, fallopian or primary peritoneal cancer

- Must have been treated previously with carboplatin, cisplatin or another
organoplatinum compound

Exclusion Criteria:

- Women who are pregnant or nursing

- History of congenital long QT syndrome

- Active bleeding or at risk of a bleeding disorder

- Other significant medical condition or history of medical condition which may put the
patient at risk

We found this trial at

sites

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland 21231

Phone: 410-502-0669

from

Baltimore, MD