Pleura and peritoneum · 2025
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.
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Popat Vinita, Frankel Paul H, Ruel Nora H, Yost Susan E, Chang Sue, Wang Edward, Villella Jeannine, Whyte Jill, Whelan Richard L, Eng Melissa, Tinsley Raechelle, Synold Tim, Han Ernest, Song Mihae, Cohen Joshua, Raoof Mustafa, Dellinger Thanh Hue
Аннотация
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/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.
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.
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/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.
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.