Phase 2
N=18
Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer
Ovarian Neoplasms Malignant (Excl Germ Cell) · Peritoneal Carcinoma · Fallopian Tube Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03480750 ↗Enrolled (actual)
18
Serious AEs
5.9%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Dose-Limiting Toxicity (DLT) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- trientine dihydrochloride (Drug); pegylated liposomal doxorubicin (Drug); carboplatin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Female
- Sponsor
- National Cheng-Kung University Hospital
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting Toxicity (DLT) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Tolerated Dose, MTD |
NA | — |
| SECONDARY Maximum Plasma Concentration [Cmax] of Trientine |
1.87; 5.07; 11.54; 14.98; 13.08; 29.35 | — |
| SECONDARY Progression-free Survival |
4.6 | — |
| SECONDARY Overall Survival |
14.4 | — |
| SECONDARY Percentage of Participants With Measurable Tumor Treatment Response Assessed by RECIST Criteria 1.1 |
43.8; 25.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histologically proved epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer after surgical staging or debulking surgery
- The first relapse within 1 year after the completion of primary platinum-based chemotherapy (partially platinum-resistant/-sensitive) or disease progression during primary chemotherapy (platinum-refractory).
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Adequate bone marrow function (absolute neutrophil count ≥ 1,500/μl, hemoglobin ≥ 9.0 g/dL and platelet count ≥ 100,000/μl)
- Serum creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance of at least 50 mL/min, total serum bilirubin ≤ 5.0 mg/dL
- Alanine transaminase (ALT) or aspartate aminotransferase (AST) ≤ 5 × upper normal limit
- Patients with reproductive potential had to agree to use an effective method of birth control prior to study entry for the duration of the study participation
- If there was no available therapy that prolonged survival for at least 3 months
Exclusion Criteria
- Patients who have metastasis to the central nervous system
- Patients who have other malignancies within 5 years prior to study entry with the exception of carcinoma in situ of the cervix uteri and non-melanoma skin cancers
- Patients who are receiving concurrent chemotherapy
- Patients who have not recovered from surgery within 4 weeks of the study;
- Patients with a clinically significant medical condition that could be aggravated by treatment or that cannot be controlled
- Patients with medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk
- Patients with known anaphylactic response or severe hypersensitivity to study drugs or their analogs
- Pregnant or lactating women
- Patients with any evidence of difficulty swallowing, intestinal obstruction or malabsorption disorder interfering with nutrition
- Patients who were unwilling or unable to provide informed consent
Data sourced from ClinicalTrials.gov (NCT03480750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.