Phase II Clinical Study of Pegylated Liposomal Doxorubicin Hydrochloride Injection as 2nd-line or Later Therapy in Patients With Mullerian Carcinoma (Epithelial Ovarian Carcinoma, Primary Carcinoma of Fallopian Tube, Peritoneal Carcinoma) Having Prior Platinum-Based Chemotherapy
Open-label Study to Verify Effectiveness, Safety of Pegylated Liposomal Doxorubicin 50 mg/m2 Administered Every 4 Weeks to Patients With Mullerian Carcinoma (Epithelial Ovarian Carcinoma, Primary Carcinoma of Fallopian Tube, Peritoneal Carcinoma) Who Have Undergone Prior Platinum-based Chemotherapy.
1 other identifier
interventional
74
0 countries
N/A
Brief Summary
The purpose of this study is to assess the effectiveness and safety of pegylated liposomal doxorubicin hydrochloride injection in Japanese patients with Mullerian carcinoma. This clinical study is a multi-center, non-randomized, open-label study in Japanese patients with Mullerian carcinoma (including epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) with a prior history of platinum-based chemotherapy. Eighty patients will be administered intravenously at least two cycles of 50 mg/m2 of pegylated liposomal doxorubicin hydrochloride every 4 weeks to investigate the effectiveness and safety of the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedMay 17, 2011
March 1, 2010
September 13, 2005
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate as antitumor effect (tumor shrinkage)
Secondary Outcomes (1)
The incidence and the severity of adverse events and adverse drug reactions; the median time to response and median duration of response and these ranges in response patients
Interventions
Eligibility Criteria
You may qualify if:
- Patients with ovarian cancer who had a response to initial treatment but then relapsed within 12 months are eligible
- Patients with ovarian cancer who have received one or two prior chemotherapy treatment are eligible
- Patients must have measurable disease, good performance status and adequate major organ function
You may not qualify if:
- Patients with concomitant disease that may affect the conduct of the study and the evaluation of pegylated liposomal doxorubicin hydrochloride
- Patients with systemic infection
- Patients with active second cancer besides the ovarian cancer
- Patients with pleural effusion or ascites requiring continuous drainage at the time of enrollment
- Patients with pericardial fluid requiring drainage
- Patients with myocardial infarction and/or angina attack within 90 days prior to enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
January 1, 2005
Study Completion
November 1, 2006
Last Updated
May 17, 2011
Record last verified: 2010-03