A phase I study of combined trabectedin and pegylated liposomal doxorubicin therapy for advanced relapsed ovarian cancer.

ABSTRACT:

Background

Advanced relapsed ovarian cancer has a poor prognosis, and treatment options are limited.

Methods

This phase I trial investigated the dosage, safety, pharmacokinetics and efficacy of trabectedin plus pegylated liposomal doxorubicin (PLD) in Japanese patients with advanced relapsed ovarian, fallopian tube, or primary peritoneal cancer. Patients received trabectedin 0.9 or 1.1 mg/m² immediately after PLD 30 mg/m²; both drugs were given by intravenous infusion. Treatment was repeated every 21 days until disease progression or unacceptable toxicity. The maximum tolerated dose (MTD) was determined in an initial dose escalation phase, and this was used in a subsequent safety assessment phase. Safety and tumor response were monitored throughout the

SUBMITTER: Takahashi S 

PROVIDER: S-EPMC8449774 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature