A Study to Compare CAELYX With Topotecan HCL in Patients With Recurrent Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
Condition: Epithelial Ovarian Cancer
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: CAELYX; Topotecan HCl
Intervention description: CAELYX 50 mg per square meter will be administered intravenously on Day 1 of each cycle as: 60 to 90-minute infusion to the participants not undergoing pharmacokinetic (PK) evaluation and 90-minute infusion to the participants undergoing for PK evaluation.; Topotecan 1.25 mg per square meter per day will be administered, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Intervention MeSH terms: Topotecan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epithelial ovarian cancer; Recurrent epithelial ovarian carcinoma; Carcinoma; Malignancy; Ovarian carcinoma; CAELYX; Topotecan hydrochloride; Topotecan; Platinum-based regimen chemotherapy; Chinese patients

Summary:

      The purpose of this study is to compare the effectiveness between CAELYX and topotecan
      hydrochloride (HCl) in Chinese participants with recurrent epithelial ovarian carcinoma
      following failure of first-line, platinum-based chemotherapy, who have received no more than
      one prior platinum-based regimen therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological diagnosed with epithelial ovarian carcinoma with measurable disease

          -  Recurrent epithelial ovarian carcinoma or disease progression following failure of
             first-line, platinum-based chemotherapy with no more than one prior platinum based
             regimen therapy

          -  Adequate laboratory values of bone marrow function, renal function, liver function,
             and echocardiogram tests

          -  Agrees to use protocol-defined effective contraception. A woman must agree not to
             donate eggs (ova, oocytes) for the purpose of assisted reproduction

          -  Disease-free from prior malignancies for more than 5 years with the exception of
             curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in
             situ of the cervix

        Exclusion Criteria:

          -  Females who are pregnant or breast feeding or planning to become pregnant while
             enrolled in this study or within 1 year after the last dose of study medication

          -  Myocardial infarct within 6 months before enrollment, class II or greater heart
             failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically
             significant pericardial disease, or electrocardiographic evidence of acute ischemic or
             active conduction system abnormalities

          -  Uncontrolled systemic infection that requires systemic anti-infective treatment

          -  Prior therapy with CAELYX or topotecan HCl

          -  Prior chemotherapy within 28 days of first dose of study medication (or 42 days if
             participant has received a nitrosourea or mitomycin)