Ignite Creation Date:
2025-12-18 @ 3:33 AM
Ignite Modification Date:
2025-12-23 @ 9:49 PM
Study NCT ID:
NCT00787488
Status:
None
Last Update Posted:
2014-11-11 00:00:00
First Post:
2008-11-06 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of IV and IP Chemotherapy Plus Abdominal Hyperthermia for Ovarian Ca
Sponsor:
None
Organization:
Study Overview
Official Title:
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:
None
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study not funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: