A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
Conditions
Ovarian Cancer - Fallopian Tube Cancer - Peritoneal Cancer
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
recurrent, persistent
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gemcitabine Type: Drug
Name: pazopanib Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Location
University of Virginia
Charlottesville, Virginia, United States
Status: Recruiting
Contact: Linda R. Duska, MD - 434-924-5100 - lduska@virginia.edu
Start Date
September 2012
Completion Date
July 2018
Sponsors
Linda R Duska
Source
University of Virginia
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page