At a glance
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Phase I Trial of Copper Chelator in Conjunction With Pegylated Liposomal Doxorubicin and Carboplatin in Patients With Platinum-resistant/-Refractory Epithelial Ovarian Cancer, Tubal Cancer and Primary Peritoneal Cancer
In Brief
A Phase 2 clinical trial evaluating trientine dihydrochloride, pegylated liposomal doxorubicin, and 1 other intervention for Ovarian Neoplasms Malignant (Excl Germ Cell) and 2 related conditions. Completed, enrolled 18 participants.
Detailed 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.
Study Details
Timeline
Interventions
trientine dihydrochloride 300MG/CAPSUE PO daily (in different dose levels)
pegylated liposomal doxorubicin 40mg/m2 IV D1
carboplatin AUC 4 IV D1