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 compared to usual care.
PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of intravenous (IV) cisplatin on the day prior to interval cytoreductive surgery (CRS) 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. 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 or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval debulking surgery Patients are randomized to 1 of 2 arms. ARM I: Patients receive cisplatin IV the day prior to interval cytoreductive surgery ARM II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes at the time of interval cytoreductive surgery 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Given IV
Given IV
Undergo CRS
Undergo HIPEC
Given IV
Ancillary studies
Ancillary studies
Undergo stool sample collection
Undergo diagnostic imaging
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGIncidence of chemotherapy-related adverse events
Defined by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
Time frame: 30 days from perioperative treatment
Feasibility of chemotherapy immediately perioperatively
Percentage of patients able to receive planned chemotherapy the day prior to surgery or HIPEC on day of surgery
Time frame: 1 Day prior to surgery and 1 day of surgery
Percentage of patients in Arm C with a treatment free interval of < 8 weeks
Percentage of patients in Arm C with a treatment free interval of \< 8 weeks
Time frame: Up to 1 year
Recurrence free survival
time between surgery and recurrence
Time frame: For 3-5 years after study
Tumor response
tumor response evaluated per clinical standards
Time frame: Up to 1 year
Quality of life (QOL) assessment EORTC QLQ-C30
Validated quality of life assessments
Time frame: Baseline up to 6 months post-treatment
Changes to the gut microbiome
metagenomic whole-genome shotgun sequencing (mWGS)
Time frame: Within one week of re-operative appointment, cycle 1 (each cycle is 28 days) of adjuvant chemotherapy and last cycle of adjuvant chemotherapy
The Ohio State University Comprehensive Cancer Center
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