# Multicenter dose de-escalation phase I trial of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel and cisplatin in combination with systemic nab-paclitaxel in recurrent ovarian cancer patients: trial in progress

## TL;DR

This clinical trial is testing a new chemotherapy approach for recurrent ovarian cancer by combining pressurized intraperitoneal drug delivery with standard systemic treatment.

## Contribution

The study introduces a novel triplet bidirectional chemotherapy regimen combining PIPAC and systemic nab-paclitaxel in recurrent ovarian cancer.

## Key findings

- The trial is evaluating safety and tolerability of PIPAC nab-paclitaxel and cisplatin with systemic nab-paclitaxel.
- Primary endpoints include dose-limiting toxicities and adverse events in recurrent ovarian cancer patients.
- Secondary outcomes include progression-free survival and histologic response.

## Abstract

Ovarian cancer (OC) often presents with peritoneal metastases (PM) which contribute significantly to morbidity and treatment resistance. Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) has emerged as a promising modality for locoregional drug delivery in peritoneal surface malignancies. Historically, combined intraperitoneal (IP) and intravenous (IV) cisplatin and paclitaxel regimens have demonstrated activity in first-line OC treatment. PIPAC nab-paclitaxel and cisplatin with systemic nab-paclitaxel holds promise as a safe and effective therapy, but has not been explored in OC.

This ongoing, dose de-escalation, single-arm phase I study evaluates triplet bidirectional chemotherapy with a safety lead-in (NCT04329494). The study evaluates the safety and tolerability of a 28-day cycle of Day 1 PIPAC nab-paclitaxel 90 mg/m2 and cisplatin 15 mg/m2 in combination with Days 8 and 15 IV nab-paclitaxel 100 mg/m2 for three cycles in recurrent OC patients with unresectable PM.

Enrollment is ongoing at U.S. academic centers. The primary endpoints are dose-limiting toxicities and adverse events. Secondary endpoints include radiographic (RECIST v1.1), histologic, and surgical response, progression-free and overall survival, and post-operative complications.

This study investigates the safety, feasibility, and preliminary activity of the combination of PIPAC and systemic IV chemotherapy in recurrent OC patients to determine efficacy and safety for a future Phase II trial.