Clinical trial NCT01840943: A Study to Compare CAELYX With Topotecan HCL in Patients With Recurrent Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
Official title: A Phase 3, Randomized, Open-Label, Comparative Bridging Study of CAELYX® Versus Topotecan HCl in Subjects With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Epithelial Ovarian Cancer
Keywords: Epithelial ovarian cancer
Recurrent epithelial ovarian carcinoma
Carcinoma
Malignancy
Ovarian carcinoma
CAELYX
Topotecan hydrochloride
Topotecan
Platinum-based regimen chemotherapy
Chinese patients
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-26
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), comparative bridging study (a supplemental study which performs to provide data of effectiveness, safety, and dosage to compare two study medications in a new region). The study consists of 3 phases: screening phase (30 days before administration of study medication), treatment phase, and follow up phase (every 8 weeks for tumor assessment until disease progression or death, or until the study completion, whichever is earlier and every 3 months after disease progression for overall survival and for anti-tumor therapy for a minimum of 1 year). In the treatment phase, approximately 120 eligible participants will be categorized prospectively for platinum-sensitivity (sensitive versus refractory) and bulky disease (presence versus absence). Later on participants will be randomly assigned either to experimental arm (CAELYX: administer on Day 1 of each cycle) or control arm (topotecan HCl: administer on Day 1 to Day 5 of each cycle). Treatment will continue until disease progression occurs and may continue for at least 2 cycles after confirmed complete response (disappearance of all target lesions). On average, it is expected that participants will continue treatment for approximately 3 to 6 cycles in experimental arm (CAELYX) or 4 to 8 cycles in Control arm (topotecan HCl). Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, echocardiogram (or multiple gated acquisition scans), vital signs, and physical examination which will be monitored throughout the study. The total duration of the study will be approximately 23 months.

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)

Primary outcomes:
measure: Number of Participants With Progression-free Survival Incidence at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Duration of Progression-free Survival
timeFrame: 1 year after the last dose (24 weeks) administration
measure: Number of Participants With Response
timeFrame: Up to Week 24
measure: Time to Response
timeFrame: Up to Week 24
measure: Duration of Response
timeFrame: Up to 1 year of last dose (Week 24) administration
measure: Health-related Quality of Life Assessment (HQL)
timeFrame: Day 1 of each cycle of study medication and Week 4 after last dose of study medication
measure: Number of Participants With Overall Survival
timeFrame: Week 4 after the last dose of the study medication and approximately up to 1 year after the disease progression or completion of the study treatment or death, whichever is earlier
measure: Maximum Plasma Concentration of CAELYX
timeFrame: 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
measure: Time to Reach the Maximum Plasma Concentration of CAELYX
timeFrame: 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
measure: Area Under the Plasma Concentration of CAELYX
timeFrame: 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
measure: Apparent Terminal Elimination Half-life of Plasma Concentration of CAELYX
timeFrame: 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
measure: Apparent Terminal Elimination Rate Constant of Plasma Concentration of CAELYX
timeFrame: 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
measure: Systemic Clearance of Plasma Concentration of CAELYX
timeFrame: 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
measure: Apparent Volume of Distribution of Plasma Concentration of CAELYX
timeFrame: 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
measure: Number of Participants With Adverse Events
timeFrame: Up to 30 days after the last dose of study medication
Other outcomes:
Locations:
city: Beijing
country: China
city: Chang Sha
country: China
city: Guangzhou
country: China
city: Jinan
country: China
city: Nanjing
country: China
city: Nanning
country: China
city: Wuhan
country: China
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: