NCT00787488

Pilot Study of IV and IP Chemotherapy Plus Abdominal Hyperthermia for Ovarian Ca

A Pilot Study of Intravenous and Intraperitoneal Chemotherapy Plus Abdominal Hyperthermia to Treat Optimally Debulked and Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mark Dewhirst · Academic / Other
• Sex: Female
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study aimed to test the feasibility and safety of administering combination chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of optimally debulked, advanced or recurrent ovarian, primary peritoneal, and fallopian tube cancer patients.

Detailed description

Day 1 of each 21 day Cycle: Paclitaxel 175 mg/m2 IV (infused over 3 hours) Day 1 or 2 of each Cycle Adequate IV hydration with normal saline (1000 ml recommended)followed by intraperitoneal infusion of 500 ml normal saline through the IP port. Cisplatin 75 mg/m2 reconstituted in 500 ml NS warmed to 37 degrees Celsius is infused IP (30 minute infusion)followed immediately by whole abdominal hyperthermia Abdominal hyperthermia will be delivered using the BSD 2000 ellipse system to target temperatures of 40-42 degrees Celsius monitored via rectally and vaginally continuing for no greater than 60 minutes after maximal 30 minute warm-up phase. Total duration of hyperthermia will be no greater than 90 minutes. Day 8: Paclitaxel 60 mg/m2 IP. Paclitaxel will be diluted and filtered initially in 1000 ml of normal saline or D5W warmed to 37 degrees Celsius. For IP administration, the patient must receive an additional 1000 ml of normal saline degrees Celsius in the peritoneal cavity. Cycles will be repeated every 3 weeks x 6 cycles. Patients will be followed until disease progression/recurrence or death.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DEVICE	Hyperthermia	Every 3 weeks

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-11-07
• Last updated: 2014-11-11