NCT01144442

WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer

WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 16 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adjuvant chemotherapy. It is expected that this first surgery was optimal - as defined as no residual tumor \> or = 1 centimeter. Patient has clinical evidence of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate) heated and administered into the abdomen, followed by hyperthermic intraperitoneal chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for 6 cycles.

Detailed description

OBJECTIVES * The primary objectives are * to determine the clinical response of hyperthermic intraperitoneal chemotherapy (HIPC) in patients at the time of first clinical recurrence of ovarian, fallopian tube, or primary peritoneal carcinoma * to determine the feasibility of delivering HIPC in a recurrent setting. * Secondary objectives are * to determine disease free survival (DFS) and overall survival (OS), * to determine treatment related changes in quality of life (QOL) * to monitor the toxicities and complications associated with HIPC.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	Hyperthermic intraperitoneal chemotherapy with Carboplatin	Carboplatin at a dose of 1000mg/m\^2 will be added to the perfusate once circulating levels reach 1000-1500cc/minute. The circulation of the chemotherapy impregnated perfusate will be performed for 90 minutes.
OTHER	Isotonic saline (perfusate)	The HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius.
PROCEDURE	Surgery	The abdominal incision will be performed in a vertical fashion extending from the supra-pubic region to around the umbilicus. If cytoreductive surgery is required, it will be performed at this time and proceed in standard approach.
DRUG	Carboplatin	The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.
DRUG	Paclitaxel	The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.

Timeline

• Start date: 2010-07-27
• Primary completion: 2013-09-25
• Completion: 2015-05-01
• First posted: 2010-06-15
• Last updated: 2019-07-30
• Results posted: 2013-09-05

Locations

1 site across 1 country: United States