Phase I Study of Pressurized Intraperitoneal Aerosol Chemotherapy with Cisplatin-Doxorubicin Combined with Standard Carboplatin-Paclitaxel Systemic Chemotherapy in Women with Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer with Incomplete Response to Prior Treatment

What this Trial Is About

Researchers are studying women with advanced ovarian, fallopian tube, or peritoneal epithelial cancer who have not had a strong enough tumor response after prior chemotherapy to allow complete surgical removal. This phase I trial aims to find the highest safe dose of a new chemotherapy delivered as a pressurized aerosol inside the abdomen PIPAC combined with standard intravenous chemotherapy. The study also looks at tumor response, changes in cancer spread, drug behavior in the body, and overall safety of this treatment approach. Participants will receive up to three 28-day treatment cycles. Each cycle includes a PIPAC procedure on Day 1 where doxorubicin and cisplatin are given at increasing doses, alongside standard carboplatin and paclitaxel chemotherapy on Day 8. Dose levels start low and increase based on patient tolerance, with protective sodium thiosulfate given from higher doses to reduce kidney risks. Treatment continues unless severe side effects occur. During the study, patients will have blood tests to measure drug levels and cancer markers, along with imaging scans to assess tumor changes. After treatment, those with tumor shrinkage or stable disease will be re-evaluated for possible surgery followed by recovery monitoring. Safety will be closely tracked throughout, including kidney function during the chemotherapy cycles. Participation lasts through treatment and post-operative follow-up if surgery is performed.

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer