Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Heated Intraperitoneal chemotherapy (HIPEC) has several potential benefits. High-dose chemotherapy can be used due to the plasma-peritoneal barrier resulting in little absorption into the blood stream. Additionally, there is higher peritoneal penetration in comparison to IV regimen, and does not hav...

Heated Intraperitoneal chemotherapy (HIPEC) has several potential benefits. High-dose chemotherapy can be used due to the plasma-peritoneal barrier resulting in little absorption into the blood stream. Additionally, there is higher peritoneal penetration in comparison to IV regimen, and does not have the limitation of traditional IP regimen of post-operative adhesions. Hyperthermia itself has cytotoxic effects and can increase the depth of tumor penetration by the chemotherapeutic agent up to 3 millimeters; moreover, hyperthermia can potentiate its antineoplastic effects. In recent times, morbidity and mortality associated with HIPEC has drastically improved. One large retrospective review of 694 patients, treated between 2005 and 2011, utilizing the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQUIP) database, demonstrated a complication rate of 33% and 30-day mortality of 2.3%, both rates consistent with outcomes for other major complex abdominal operations. Recently, a Phase I dose escalation study to evaluate maximum tolerated dose (MTD) of HIPEC administration of cisplatin in recurrent epithelial ovarian cancer (EOC) patients was published. The MTD of cisplatin was 100 milligrams per meter squared (mg/m2) with no mortality or safety concerns. While the trial had only 12 patients, all were able to receive post-operative IV chemotherapy, with all patients completing at least five cycles. In protocol Gynecologic Oncology Group (GOG)-0172, intraperitoneal cisplatin and paclitaxel, plus intravenous paclitaxel, demonstrated the longest median survival reported in optimally debulked stage III ovarian cancer. Currently, the GOG is studying variations of the intraperitoneal (IP) regimen to preserve the survival advantage, but make it tolerable for patients to receive 6 cycles without discontinuing therapy due to distress and toxicity. The importance of developing an acceptable GOG-0172 alternative is emphasized by the recent National Cancer Institute (NCI) Clinical Announcement recognizing the superiority of intraperitoneal chemotherapy in the optimal disease setting.

Tracking Information

NCT #
NCT03321188
Collaborators
University of Kansas Medical Center
Investigators
Principal Investigator: Andrea Jewell, MD The University of Kansas - Cancer Center