A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	June 23, 2008
Last Updated Date	July 31, 2008
Start Date ^†	November 2004
Current Primary Outcome Measures ^† (submitted: August 4, 2008)	Evaluation of efficacy of Caelyx, namely, the rate of objective response, stabilization and progression [ Time Frame: Chest X-ray, CT, MRI will be performed every 2 cycles, last day of last cycle, and 4 weeks after chemotherapy is completed. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00727961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: August 4, 2008)	Time to response [ Time Frame: 28 days after the last cycle ] [ Designated as safety issue: No ] Duration of response [ Time Frame: 28 days after the last cycle ] [ Designated as safety issue: No ] Time to disease progression [ Time Frame: 28 days after the last cycle ] [ Designated as safety issue: No ] Number of patients withdrawn from the treatment due to intolerance [ Time Frame: 28 days after the last cycle ] [ Designated as safety issue: No ] Survival [ Time Frame: 28 days after the last cycle ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)
Official Title ^†	Obligatory Post-Registration Open-Label, Non-Comparative Multicenter Study of Efficacy and Tolerance Rate of Caelyx as Monotherapy in Patients With Epithelial Ovarian Cancer, Resistant to Previous Platinum Therapy.
Brief Summary	The aim of this study is to evaluate efficacy and tolerability, and number of positive response to treatment with CAELYX (50 mg/m^2), administered as monotherapy once per 4 weeks to patients with metastatic epithelial ovarian cancer, resistant to previous platinum therapy.
Detailed Description
Study Phase	Phase IV
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Condition ^†	Ovarian Neoplasms
Intervention ^†	Drug: Pegylated Liposomal Doxorubicin hydrochloride
Study Arms / Comparison Groups	Experimental: Caelyx IV, 50 mg/m^2, given for 6 cycles
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	58
Completion Date	January 2008
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent. Women must be 18-65 year of age, of any race. Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation). Morphology (cytology or histology) confirmed diagnosis of epithelial ovarian cancer. Patients with 1 or more measurable and/or evaluable tumors, according to the results of CT, MRT scans or X-ray, etc. Patients, including those after primary surgical treatment, who had previously received platinum chemotherapy and in whom second-line therapy is indicated. Karnofsky performance status above 60%. Left ventricular ejection fraction above 50% (according to the results of echocardiography). Adequate bone marrow function as indicated by: Platelets >100x10^9/L Haemoglobin > 9 g/dL Absolute neutrophil count >1.5x10^9/L Adequate renal function as indicated by: Serum creatinine < 1.5 х ULN Adequate liver function as indicated by: Bilirubin level and AST or ALT activity < 2 х ULN (with the exception of cases related to primary disease). Exclusion Criteria: Women who are pregnant or nursing. Subjects who have not observed the designated washout periods for any of the prohibited medications. Subjects who have used any investigational product within 30 days prior to enrollment. Medical history indicating serious concomitant diseases, such as congestive heart failure of II NYHA class or higher, insulin-dependent diabetes mellitus, clinically significant liver disease, mental disorders. Non-controlled bacterial, viral or fungal infections. Conditions and reasons (medical, social and psychological) that might prevent adequate follow-up of patients. Any other active primary tumor under treatment (except basal or squamous cell carcinoma or in situ cervix carcinoma). Patient has symptomatic metastasis to brain.
Gender	Female
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00727961
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Secondary IDs ^††
Study Sponsor ^†	Schering-Plough
Collaborators ^††
Investigators ^†
Information Provided By	Schering-Plough
Verification Date	July 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.