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

Study ID
STU 112016-090

Study Sites

  • CTRC Outpatient

Contact
Isabel Villalobos
214/648-7010
isabel.villalobos@utsouthwestern.edu

Principal Investigator
Debra Richardson

Official Title

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

Brief Overview

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.

Description

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.

Eligibility

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