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

  • Interventional
  • Recruiting
  • NCT03029585
Eligibility Details Visit Clinicaltrials.gov

Phase II Study of Four Dose Levels of Intraperitoneal NanoPac® Plus IV Carboplatin and Paclitaxel in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery

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.

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-cytoreductive surgery in women with 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.

Gender
Female

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03029585

IRB#IRB16-1602

Lead SponsorNanOlogy, LLC

Lead PhysicianSeiko Diane Yamada

Collaborator(s)N/A

EligibilityFemale
18 Years and up
Recruiting