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

NCT ID: NCT03029585

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-19
• Study Completion Date: 2019-11-04

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.

Conditions

Ovarian Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NanoPac® 100 mg/m2

Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.

Group Type: EXPERIMENTAL

NanoPac® 100 mg/m2

Intervention Type: DRUG

Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Standard of Care Intravenous Chemotherapy

Intervention Type: DRUG

Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment

NanoPac® 200 mg/m2

Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.

Group Type: EXPERIMENTAL

NanoPac® 200 mg/m2

Intervention Type: DRUG

Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Standard of Care Intravenous Chemotherapy

Intervention Type: DRUG

Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment

NanoPac® 300 mg/m2

Intraperitoneal NanoPac® 300 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.

Group Type: EXPERIMENTAL

NanoPac® 300 mg/m2

Intervention Type: DRUG

Single intraperitoneal injection of 300 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Standard of Care Intravenous Chemotherapy

Intervention Type: DRUG

Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment

NanoPac® 400 mg/m2

Intraperitoneal NanoPac® 400 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.

Group Type: EXPERIMENTAL

NanoPac® 400 mg/m2

Intervention Type: DRUG

Single intraperitoneal injection of 400 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Standard of Care Intravenous Chemotherapy

Intervention Type: DRUG

Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Standard of Care Intravenous Chemotherapy

Standard of care intravenous chemotherapy (with platinum and taxane agents) administered per institutional standards.

Group Type: ACTIVE_COMPARATOR

Standard of Care Intravenous Chemotherapy

Intervention Type: DRUG

Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Interventions

NanoPac® 100 mg/m2

Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Intervention Type: DRUG

NanoPac® 200 mg/m2

Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Intervention Type: DRUG

NanoPac® 300 mg/m2

Single intraperitoneal injection of 300 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Intervention Type: DRUG

NanoPac® 400 mg/m2

Single intraperitoneal injection of 400 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Intervention Type: DRUG

Standard of Care Intravenous Chemotherapy

Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

US Biotest, Inc.

INDUSTRY

Sponsor Role: collaborator

NanOlogy, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan Walker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Gere diZerega, MD

Role: STUDY_CHAIR

US Biotest, Inc./NanOlogy, LLC

Locations

University of Chicago

Chicago, Illinois, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, United States

SUNY Downstate

Brooklyn, New York, United States

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

University of Texas Southwestern

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NANOPAC-2016-01

Identifier Type: -

Identifier Source: org_study_id