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

Linda R Duska

Status and phase

Completed

Phase 2

Conditions

Peritoneal Cancer

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Drug: pazopanib

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01610206

16153

Details and patient eligibility

About

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.

Enrollment

148 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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