A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Pegylated Liposomal Doxorubicin hydrochloride
Intervention description: Caelyx Intravenous, 50 mg/m^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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 greater than or equal to 18 years 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.