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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00216645
First Posted: September 22, 2005
Last Update Posted: May 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Janssen Pharmaceutical K.K.
  Purpose
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.

Condition Intervention Phase
Ovarian Neoplasms Drug: doxorubicin hydrochloride Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Overall response rate as antitumor effect (tumor shrinkage)

Secondary Outcome Measures:
  • 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

Enrollment: 74
Study Start Date: January 2005
Study Completion Date: November 2006
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.
  Eligibility

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216645


Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00216645     History of Changes
Other Study ID Numbers: CR004867
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: May 17, 2011
Last Verified: March 2010

Keywords provided by Janssen Pharmaceutical K.K.:
Müllerian Carcinoma
Doxil
Japanese Patients

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fallopian Tube Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Carcinoma
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action