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

Sponsor
National Cheng-Kung University Hospital
Study ID
NCT03480750
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Fallopian Tube Cancer
  • Ovarian Neoplasms Malignant (Excl Germ Cell)
  • Peritoneal Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • trientine dihydrochloride — DRUG
    trientine dihydrochloride 300MG/CAPSUE PO daily (in different dose levels)
  • pegylated liposomal doxorubicin — DRUG
    pegylated liposomal doxorubicin 40mg/m2 IV D1
  • carboplatin — DRUG
    carboplatin AUC 4 IV D1

Study Details

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.

Key Dates

First listed
Mar 29, 2018
Start date
Sep 30, 2012
Status verified
Oct 2020
Primary completion
Oct 31, 2015
Completion
Dec 31, 2019

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: trientine with chemotherapy
    trientine dihydrochloride PO daily (in different dose levels) plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicity (DLT) [ Time Frame: 36 days ]

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