Clinical trial NCT03029585: Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Carcinoma
Keywords: ovarian carcinoma
ovarian cancer
ovarian neoplasms
ovarian diseases
Lead sponsor: NanOlogy, LLC
Sponsor class: INDUSTRY
Collaborators: name: US Biotest, Inc.
First posted: 2017-01-24
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 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

Primary outcomes:
measure: Treatment-emergent Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Maximum Plasma Concentration of Paclitaxel (Cmax)
timeFrame: 12 months
measure: Progression Free Survival (PFS) at 12 Months
timeFrame: 12 months post-treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Brooklyn
country: United States
facility: SUNY Downstate
state: New York
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: University of Oklahoma
name: Joan Walker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: US Biotest, Inc./NanOlogy, LLC
name: Gere diZerega, MD
role: STUDY_CHAIR
References: