Brief Title
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
Official Title
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
Brief Summary
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free Survival
Secondary Outcome
Number of Participants With Adverse Events
Condition
Ovarian Cancer
Intervention
Gemcitabine
Study Arms / Comparison Groups
gemcitabine
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
148
Start Date
September 2012
Completion Date
December 31, 2020
Primary Completion Date
June 1, 2018
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Linda Duska, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01610206
Organization ID
16153
Responsible Party
Sponsor-Investigator
Study Sponsor
Linda R Duska
Collaborators
Novartis
Study Sponsor
Linda Duska, MD, Study Director, University of Virginia School of Medicine
Verification Date
February 2021