Status:
COMPLETED
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
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
20-79 years
Phase:
PHASE2
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 m...
Detailed Description
Pegylated liposomal Doxorubicin hydrochloride is intended to change the pharmacokinetics of conventional doxorubicin in the blood and to improve the safety and effectiveness of the drug. Pegylated lip...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00216645
Start Date
January 1 2005
End Date
November 1 2006
Last Update
May 17 2011
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