Status:
COMPLETED
Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Ovarian Neoplasms Malignant (Excl Germ Cell)
Peritoneal Carcinoma
Eligibility:
FEMALE
20-75 years
Phase:
PHASE1
PHASE2
Brief 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 r...
Detailed Description
Epithelial ovarian cancer, tubal, primary peritoneal cancers are lethal gynecologic malignances, with a 5-year survival rate below 25% for patients diagnosed with stage III-IV. Most advanced stage pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03480750
Start Date
September 1 2012
End Date
December 1 2019
Last Update
November 10 2020
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