This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Hyperthermic intraepithelial chemotherapy involves the infusion of heated cytotoxic chemotherapy that circulates into the abdominal cavity at the time of surgery. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery may kill more tumor cells.
Additional locations may be listed on ClinicalTrials.gov for NCT05415709.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Floor Backes
Phone: 614-293-7642
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of intravenous (IV) cisplatin on the day prior to interval cytoreductive surgery (CRS) compared to administration of hyperthermic intraepithelial chemotherapy (HIPEC) with cisplatin at the completion of interval cytoreductive surgery.
SECONDARY OBJECTIVES:
I. Feasibility of each of the treatment options.
II. Treatment delays.
III. Perioperative outcomes.
IV. Quality of life/patient reported outcomes.
V. Recurrence free survival (RFS) and overall survival (OS).
VI. Assess changes to the gut microbiome.
OUTLINE:
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third cycle, patients who achieve complete or partial response undergo CRS.
Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cisplatin IV the day prior to CRS.
ARM II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes in the absence of disease progression or unacceptable toxicity.
All patients undergo stool sample collection and diagnostic imaging throughout the trial.
After completion of study treatment, patients are followed up for up to 30 days.
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorFloor Backes