Pilot Study of IV and IP Chemotherapy Plus Abdominal Hyperthermia for Ovarian Ca
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Clinically free of disease. Response definitions will be based on CA-125, clinical assessment, CT imaging [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Chemotherapy plus Hyperthermia
Every 3 weeks
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787488
|Principal Investigator:||Elizabeth Jewell, MD||Duke University|
|Principal Investigator:||Angeles Secord, MD||Duke University|
|Principal Investigator:||Ellen Jones, MD, PhD||Duke University Medical Center, Radiation Oncology|