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.
- 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
- 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).
- Women who are pregnant or nursing.
- Subjects who have not observed the designated washout periods for any of the
- Subjects who have used any investigational product within 30 days prior to
- 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.