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Phase II Study of Four Concentrations of Intraperitoneal NanoPac® Plus Six Cycles of IV Carboplatin and Paclitaxel in Patients With Platinum-Sensitive Recurrent Stage III Epithelial Ovarian Cancer Undergoing Second Cytoreductive Surgery (NCT03029585)

US Biotest, Inc.
This study will evaluate NanoPac® administered intraperitoneally (IP) immediately post-second cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy, in women with with platinum-sensitive recurrent ovarian cancer. The study will compare IP NanoPac® (plus IV chemotherapy) with SOC IV chemotherapy alone.
  • Drug: NanoPac® 100 mg/m2
    Single intraperitoneal injection of 100 mg/m2 NanoPac® during second cytoreductive surgery, followed by six cycles of standard-of-care IV carboplatin and IV paclitaxel treatment
    • Drug: NanoPac® 200 mg/m2
      Single intraperitoneal injection of 200 mg/m2 NanoPac® during second cytoreductive surgery, followed by six cycles of standard-of-care IV carboplatin and IV paclitaxel treatment
      • Drug: NanoPac® 300 mg/m2
        Single intraperitoneal injection of 300 mg/m2 NanoPac® during second cytoreductive surgery, followed by six cycles of standard-of-care IV carboplatin and IV paclitaxel treatment
        • Drug: NanoPac® 400 mg/m2
          Single intraperitoneal injection of 400 mg/m2 NanoPac® during second cytoreductive surgery, followed by six cycles of standard-of-care IV carboplatin and IV paclitaxel treatment
          • Drug: Standard of Care Intravenous Chemotherapy
            Second cytoreductive surgery followed by six cycles of standard-of-care IV carboplatin and IV paclitaxel treatment
            Ages eligible for Study
            18 Years and older
            Genders eligible for Study
            Female
            Accepts Healthy Volunteers
            No
            Inclusion Criteria:
            • First recurrence of stage III epithelial ovarian cancer or stage IV epithelial cancer if non-peritoneal cavity disease is limited to pleural effusions
            • Platinum-sensitive cancer (recurrence >6 months from prior chemotherapy regimen that included a platinum agent and cytoreductive surgery)
            • Subject appropriate for second cytoreductive surgery and treatment with IV platinum and paclitaxel
            • Ascites <500 mL; radiologic or ultrasound determination (pre-surgery)
            • ≥18 years old
            • Signed informed consent
            Exclusion Criteria:
            • Epithelial ovarian cancer outside of the peritoneal cavity, with the exception of pleural effusions
            • More than one prior cytoreductive surgery
            • 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®
            • 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 cytoreductive surgery
            • Women of childbearing potential not practicing adequate forms of birth control
            The standard of care for women experiencing a recurrence of platinum-sensitive ovarian cancer is cytoreductive surgery followed by intravenous (IV) chemotherapy with a platinum agent (e.g., carboplatin) and a taxane (e.g., paclitaxel). Research has shown that the administration of chemotherapy directly into the peritoneal cavity (intraperitoneal [IP] chemotherapy) may provide a significant survival benefit to women with ovarian cancer when combined with cytoreductive surgery and IV chemotherapy.

            This study will include a dose-finding phase and an efficacy phase to evaluate IP NanoPac® administered immediately post-second cytoreductive surgery in women with platinum-sensitive ovarian cancer. In the dose-finding phase, subjects will be enrolled in dose-escalated cohorts of three subjects and receive IP NanoPac® at 100, 200, 300, or 400 mg/m2 plus standard of care (SOC) IV chemotherapy. Subjects will be followed for disease status for 12 months. The two best doses from the dose-finding phase will be determined. In the efficacy phase, subjects will be randomized 1:1:1 to one of the two best doses plus SOC IV chemotherapy or SOC alone.

            7 locations

            United States (7)
            • University of Chicago
              recruiting
              Chicago, Illinois, United States, 60637
            • Greater Baltimore Medical Center
              recruiting
              Baltimore, Maryland, United States, 21204
            • SUNY Downstate
              recruiting
              Brooklyn, New York, United States, 11203
            • University of Oklahoma
              recruiting
              Oklahoma City, Oklahoma, United States, 73104
            • Magee-Womens Hospital of UPMC
              recruiting
              Pittsburgh, Pennsylvania, United States, 15213
            • Women & Infants Hospital in Rhode Island
              recruiting
              Providence, Rhode Island, United States, 02905
            • University of Texas Southwestern
              recruiting
              Dallas, Texas, United States, 75390
            Status:
            recruiting
            Type:
            Interventional
            Phase:
            Start:
            18 April, 2017
            Updated:
            27 June, 2017
            Participants:
            61
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