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Seprafilm™ for the Prevention of Intraperitoneal Adhesions and Improved Delivery of Therapy in Women Undergoing Staging and Intraperitoneal Chemotherapy for Advanced Ovarian Cancer


N/A
N/A
N/A
Open (Enrolling)
Female
Epithelial Ovarian Cancer

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Trial Information

Seprafilm™ for the Prevention of Intraperitoneal Adhesions and Improved Delivery of Therapy in Women Undergoing Staging and Intraperitoneal Chemotherapy for Advanced Ovarian Cancer


The recommended treatment of epithelial ovarian cancer (EOC) includes optimal surgical
debulking to < 1 cm residual disease, followed by a combination of intraperitoneal (IP) and
intravenous (IV) chemotherapy for at least 6 cycles. Serous EOC is known to spread
transperitoneally and is often diffusely disseminated within the peritoneal cavity. It is
believed that IP therapy via direct contact is effective in treating such small
intraperitoneal implants. What is not known is whether IP therapy is evenly distributed in
individuals and to what degree adhesions and formation of scar tissue prevents the even
distribution of chemotherapy within the belly, potentially impacting efficacy. Few studies
have addressed the question of adhesions and intraperitoneal therapy in general, and there
have been no studies specifically in ovarian cancer utilizing current guidelines. Efficacy
has been proven for IP/IV therapy over IV alone but the range of survival within the IP
group may be secondary to "tumor biology," patient selection (i.e., disease truly > 1 cm) or
lack of/poor distribution of IP drug secondary to adhesions. Any product that could be shown
to decrease those adhesions and increase the area of distribution of IP therapy would prove
a major advantage.

The majority of scarring and adhesions take place in the first 7 days after a surgical
procedure. And the first IP and IV chemotherapy usually commences between 7-21 days after
surgery. Therefore, the first treatment provides an opportunity to assess intraperitoneal
adhesions. To assess adhesions, we will inject radiopaque dye (iohexol) via the IP port,
rotate the patient per the standard practice during IP therapy to distribute the injected
liquid, and then take 3 views (simple X-rays) of the abdomen. The area of distribution of
the dye (representing distribution of IP chemotherapy) will be compared in two groups of
subjects (Seprafilm™ vs. no Seprafilm™).


Inclusion Criteria:



- Epithelial ovarian cancer

- Stage III or IV (advanced)

- Planned intraperitoneal chemotherapy

- Optimally debulked to less than 1 cm residual tumor in any area within the peritoneal
cavity (after consent prior to randomization)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

The area of distribution of contrast dye in the intraperitoneal cavity as measured on three abdominal films taken 7-10 days following debulking surgery for epithelial ovarian cancer.

Outcome Time Frame:

7-10 days

Safety Issue:

No

Principal Investigator

Dr. Dianne Miller

Investigator Role:

Study Director

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

Canada: Health Canada

Study ID:

H09-03436

NCT ID:

NCT01095367

Start Date:

April 2010

Completion Date:

December 2012

Related Keywords:

  • Epithelial Ovarian Cancer
  • Adhesion barrier sheets
  • ovarian cancer
  • Advanced stage epithelial ovarian cancer
  • Tissue Adhesions
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

University of Nevada School of MedicineReno, Nevada  89503