A phase I trial of intraperitoneal nab-paclitaxel in the treatment of advanced malignancies primarily confined to the peritoneal cavity.
Cancer chemotherapy and pharmacology
Intraperitoneal chemotherapy; Nab-paclitaxel; Peritoneal carcinomatosis; ovarian cancer; Pharmacologic advantage
PURPOSE: To evaluate intraperitoneal (IP) nab-paclitaxel in patients with advanced malignancies that are primarily confined to the peritoneal cavity in a phase I trial.
METHODS: Using a 3 + 3 dose escalation of IP nab-paclitaxel on days 1, 8, and 15 of a 28-day cycle, we evaluated six dose levels (35-175 mg/m
RESULTS: There were no dose-limiting toxicities (DLTs) in cohorts 1-3. There was a DLT in one of six patients in cohort 4 (112.5 mg/m
CONCLUSIONS: Weekly IP nab-paclitaxel has a favorable toxicity profile, a significant pharmacologic advantage, and promising clinical activity.
CLINICAL TRIAL REGISTRATION: NCT00825201.
Cristea, Mihaela C; Frankel, Paul; Synold, Timothy; Rivkin, Saul Eugene; Lim, Dean; Chung, Vincent; Chao, Joseph; Wakabayashi, Mark; Paz, Benjamin; Han, Ernest; Lin, Paul; Leong, Lucille; Hakim, Amy; Carroll, Mary; Prakash, Neal; Dellinger, Thanh; Park, Min; and Morgan, Robert J, "A phase I trial of intraperitoneal nab-paclitaxel in the treatment of advanced malignancies primarily confined to the peritoneal cavity." (2019). Articles, Abstracts, and Reports. 1106.