A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
Completed · Phase 2
Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
In brief
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.
Key facts
- Study ID
- NCT01610206
- Run by
- Linda R Duska
- People needed
- 148
- Starts
- 2012-09-01
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2021-02-25
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Maine Medical Center (MMP Women's Health) — Scarborough, Maine, United States
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
- Duke University — Durham, North Carolina, United States
- Stephenson Cancer Center University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- MD Anderson — Houston, Texas, United States
- University of Virginia — Charlottesville, Virginia, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- University of Wisconsin-Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.