Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer

Inclusion Criteria:

Epithelial ovarian cancer which is contained within the abdomen, but may include pleural effusion if that is the limit of non-peritoneal cavity disease. If subject has recurrent epithelial ovarian cancer, the disease must be platinum sensitive (recurrence >6 months from prior chemotherapy regimen that included a platinum agent and cytoreductive surgery)
Subject appropriate for cytoreductive surgery and treatment with IV platinum and paclitaxel
Minimal or non-symptomatic ascites
≥18 years old
Signed informed consent

Exclusion Criteria:

Epithelial ovarian cancer outside of the peritoneal cavity, with the exception of pleural effusions
Anticipated use of concomitant chemotherapy (other than the protocol-specified agents), immunotherapy, or radiation therapy
Treatment with a prior investigational agent within 30 days of planned instillation of NanoPac®, with the exception of subjects participating in poly (ADP-ribose) polymerase (PARP) inhibitor trials. These subjects must discontinue the investigational agent prior to surgery
Known sensitivity to any of the study medication components or the chemotherapy regimen
History of prior malignancy other than ovarian that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma or cervical carcinoma in situ on biopsy
Ileostomy or hepatic resection during current cytoreductive surgery
Women of childbearing potential not practicing adequate forms of birth control