Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer
Condition: Ovarian Carcinoma
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: NanoPac® 100 mg/m2; NanoPac® 200 mg/m2; NanoPac® 300 mg/m2; NanoPac® 400 mg/m2; Standard of Care Intravenous Chemotherapy
Intervention description: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment; Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment; Single intraperitoneal injection of 300 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment; Single intraperitoneal injection of 400 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment; Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian carcinoma; ovarian cancer; ovarian neoplasms; ovarian diseases

Summary:

      This study will evaluate NanoPac® administered intraperitoneally (IP) immediately
      post-cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy,
      in women with ovarian cancer. The study will compare IP NanoPac® (plus IV chemotherapy) with
      SOC IV chemotherapy alone.
    

Eligibility criteria:

        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