NCT03321188

Heated Intraperitoneal Chemotherapy in Primary Ovarian Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Andrea Jewell · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the use of Heated Intraperitoneal Chemotherapy (HIPEC) for primary treatment of ovarian cancer at the time of surgical debulking, to assess if intravenous (IV) chemotherapy can be started within 42 days of HIPEC and cytoreduction. All patients will receive cytoreductive surgery followed by a one-time closed HIPEC with cisplatin at 41-43 degrees Celsius for 90 minutes in the operating room. This is followed by 6 cycles of intravenous carboplatin and paclitaxel on an outpatient basis.

Detailed 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 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.

Conditions

• Ovarian Cancer
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
PROCEDURE	HIPEC	HIPEC with cisplatin
DRUG	Carboplatin	Adjuvant IV chemotherapy
DRUG	Paclitaxel	Adjuvant IV chemotherapy

Timeline

• Start date: 2017-12-15
• Primary completion: 2023-12-15
• Completion: 2024-12-15
• First posted: 2017-10-25
• Last updated: 2023-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study