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

Ovarian Neoplasms Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216645
• Other study ID #: CR004867
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: May 16, 2011
• Start date: January 2005
• Est. completion date: November 2006

Study information

• Verified date: March 2010
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• doxorubicin hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate as antitumor effect (tumor shrinkage)
Secondary	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

External Links

•   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