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
Year: 2025
Type: article
Abstract: Objectives 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. Methods 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/m 2 and cisplatin 15 mg/m 2 in combination with Days 8 and 15 IV nab-paclitaxel 100 mg/m 2 for three cycles in recurrent OC patients with unresectable PM. Results 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. Conclusions 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.
Source: Pleura and Peritoneum
DOI: 10.1515/pp-2025-0036
Authors: Vinita Popat, Paul H. Frankel, Nora H. Ruel, Susan E. Yost, Sue Chang, Edward Wang, Jeannine Villella, Jill Whyte, Richard L. Whelan, Melissa Eng, Raechelle Tinsley, Tim Synold, Ernest Han, Mihae Song, Joshua Cohen, Mustafa Raoof, Thanh Hue Dellinger
Institutions: City Of Hope National Medical Center, Northwell Health
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,187
Awards: G772794905, G9000092632
OpenAlex ID: W4417535955