Where does OCRA's clinical trial data come from?

OCRA indexes clinical trials from ClinicalTrials.gov, the official U.S. registry maintained by the National Library of Medicine. Trials are matched to diseases, investigators, and funded research tracked across the platform.

How do I find clinical trials for ovarian cancer?

Search by condition, treatment type, trial phase, or NCT identifier. Each trial page shows current status, eligibility criteria, study locations, and a direct link to the ClinicalTrials.gov source record.

How often is clinical trial data updated?

Trial data is refreshed through periodic ingestion from the ClinicalTrials.gov v2 API. Status changes, new enrollments, and newly registered trials are captured during each update cycle.

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

NCT00216645CompletedPHASE2INTERVENTIONAL

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.

Key Facts

Lead Sponsor

Janssen Pharmaceutical K.K.

Enrollment

Start Date

2005-01-01

Study Type

INTERVENTIONAL

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.

Interventions

doxorubicin hydrochloride

Conditions

Ovarian Neoplasms

Eligibility

Age Range

20 Years – 79 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Overall response rate as antitumor effect (tumor shrinkage)

Secondary Outcomes

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

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.