Randomized Phase I Study Assessing the Safety and Tolerability Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at Completion of Interval Cytoreductive Surgery Compared to Surgery and Chemotherapy Prior to Surgery for Patients With Stage III/IV Ovarian Cancer Undergoing Neoadjuvant Chemotherapy.
Summary
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.
Detailed description
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.
Arms & interventions
- DrugCarboplatin
Given IV
- DrugCisplatin
Given IV
- ProcedureCytoreductive Surgery
Undergo CRS
- DrugHyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
- DrugPaclitaxel
Given IV
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureBiospecimen Collection
Undergo stool sample collection
- ProcedureDiagnostic Imaging
Undergo diagnostic imaging
Outcome measures
Primary
Incidence 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
Secondary
Feasibility of chemotherapy immediately perioperatively
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
Time frame: Up to 1 year
Recurrence free survival
Time frame: For 3-5 years after study
Tumor response
Time frame: Up to 1 year
Quality of life (QOL) assessment EORTC QLQ-C30
Time frame: Baseline up to 6 months post-treatment
Changes to the gut microbiome
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
Eligibility criteria
Study locations (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210