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This is an open-label, pilot study in patients with a diagnosis of primary 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) is 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 up to 6 cycles.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hyperthermic intraperitoneal chemotherapy with Carboplatin, Isotonic saline (perfusate), Surgery, Carboplatin, Paclitaxel
Masonic Cancer Center, University of Minnesota
Not yet recruiting
Masonic Cancer Center, University of Minnesota
Published on BioPortfolio: 2014-08-27T03:12:54-0400
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