drugset / Trial / NCT03480750

Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer

NCT03480750

Phase 1/2 Completed 18 enrolled National Cheng-Kung University Hospital
NaSingle-groupOpen-labelTreatment

Summary

Epithelial ovarian cancer (EOC) is the leading cause of gynecological malignancy-related deaths worldwide and is a substantial health threat to women. Many patients eventually develop chemoresistant relapsed disease and die despite surgery and combination chemotherapy. Progress in improving the survival in EOC has been slow, despite significant advances in treatment over the past 25 years. Tubal cancer and peritoneal cancer are thought to be similar in their origin, characteristics and treatment strategies. Based upon basic and animal studies, it is thought that copper chelators overcome platinum resistance. Thus, Trientine combined with carboplatin has been used to treat human cancers. The adverse effects (AEs) are acceptable in previously heavily-treated recurrent ovarian cancer patients, however, the treatment responses are limited. Therefore, here the investigators conduct a phase I trial of Trientine®, pegylated doxorubicin and carboplatin to find the dose-limited toxicities, and maximal toxicity dosage, and to explore whether the combination is applicable in epithelial ovarian, tubal and peritoneal cancers.

Timeline

Start
2012-09
Primary completion
2015-10
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Subject trientine Unknown 300 mg Oral
Subject trientine Unknown 1800 mg Oral
Background Carboplatin Small molecule 4 unknown Intravenous
Background Doxorubicin Other / unclassified 40 mg/m2 Intravenous