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

NCT ID: NCT00216645

Last Updated: 2011-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2006-11-30

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.

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 liposomal doxorubicin hydrochloride has been approved in many countries including US and EU, becoming a standard drug for 2nd-line therapy in ovarian cancer and AIDS-related Kaposi's Sarcoma. This clinical study was planned to assess effectiveness and safety for Japanese patients with Müllerian carcinoma (including epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma), who had a prior history of receiving platinum-based chemotherapy such as Cisplatin (which is considered to be the standard chemotherapy for ovarian carcinoma). In this study, at least two cycles of pegylated liposomal doxorubicin hydrochloride 50 mg/m2 will be intravenously administered to 80 patients every 4 weeks. These patients include twenty 2nd-line "platinum-sensitive" and sixty "platinum-resistant" 2nd-line or 3rd-line patients. Pegylated liposomal doxorubicin hydrochloride 50 mg/m2 will be given by intravenous drip infusion on day 1. After this, a 27-day drug-free period will be followed as one cycle. At least two cycles will be given as long as the patient does not meet the discontinuation criteria.

Conditions

Ovarian Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

doxorubicin hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Janssen Pharmaceutical K.K. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=405&filename=CR004867_CSR.pdf

Phase 2 Clinical study of JNS002 ( DOXILTM ) in patients with Mullerian Carcinoma (epithelial ovarian carcinoma,primary carcinoma of fallopian tube,peritoneal carcinoma ) Having a Therapeutic History of Platinum-Based Chemotherapy

Other Identifiers

CR004867

Identifier Type: -

Identifier Source: org_study_id