Safety and Pharmacokinetics of Intraoperative Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) With Cisplatin to Treat Platinum-sensitive Recurrent Ovarian Cancer (HIPEC ROC I)
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|ClinicalTrials.gov Identifier: NCT01387399|
Recruitment Status : Unknown
Verified February 2013 by Oliver Zivanovic, University Hospital, Bonn.
Recruitment status was: Active, not recruiting
First Posted : July 4, 2011
Last Update Posted : February 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Procedure: Cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Intraoperative Hyperthermic Intraperitoneal Chemoperfusion With Cisplatin in Patients With Recurrent Ovarian Cancer|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||July 2013|
Experimental: Cisplatin as HIPEC
Phase I dose escalating study of cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion
Procedure: Cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion
Classical "3+3" dose escalation study of cisplatin administered as HIPEC (60mg/m², 80mg/m² and 100mg/m²)
- Dose-limiting toxicity [ Time Frame: within the first 21days after surgery ]To determine the safety and maximum tolerated dose (MTD) of cisplatin (60 mg/m², 80mg/m² and 100 mg/m²) administered as intraperitoneal hyperthermic chemoperfusion defined by the dose-limiting toxicity (DLT).
- Pharmacokinetics [ Time Frame: within 24 hours of HIPEC ]Blood and peritoneal concentrations of cisplatin will be measured at various time points within the first 24 hours after HIPEC. The elimination half-life and the area under the plasma concentration time curve of cisplatin will be measured. Peritoneal and systemic clearance and distribution of cisplatin will be modeled in a compartmental model.
- Number of cycles of standard intravenous platinum-based systemic chemotherapy [ Time Frame: 3 months ]Measure the effect of cisplatin as HIPEC on the ability to subsequently administer 6 cycles of standard intravenous platinum-based systemic chemotherapy.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387399
|Bonn, Germany, 53127|
|Principal Investigator:||Oliver Zivanovic, MD||University Hospital, Bonn|