Phase II, Open-Label, Study of CAELYX and Carboplatin Intermediate Platinum-Sensitive (6-12 Months Treatment-Free Interval) Relapsed Epithelial Ovarian Cancer.
- Age >=18 years old
- Subject must have histological diagnosis of epithelial ovarian cancer
- Subject must have received a taxane and platinum regimen and have maintained a
treatment-free status for at least six months and not more than twelve months
following completion of first line therapy.
- Subject must have measurable ovarian cancer by appropriate radiological imaging.
- ECOG performance Score of 0 or 1.
- Subject's life expectancy must be > 6 months.
- Subject must have normal organ function, except if abnormal due to tumor involvement:
- Adequate bone marrow function (platelets >=100 X 10^9/L, hemoglobin >=100 g/L,
neutrophils >=1.5 X 10^9/L)
- Adequate renal function (serum creatinine<=1.5 X the upper limit of normal (ULN)
- Adequate liver function (bilirubin and AST or ALT<=2 times ULN, unless related
to primary disease.
- MUGA scan must indicate left ventricular ejection fraction above 90%.
- Women of childbearing potential must be using adequate contraception (prescribed
under medical supervision) and have a negative pregnancy test at the time of
- Subject must be able to sign written informed consent.
- Subject who is pregnant or is breast feeding.
- Subject who has history of cardiac disease, with New York Heart Association Class II
- Subject with a history of severe hypersensitivity reactions to products containing
- Subject with clinically significant hepatic disease.
- Subject who has uncontrolled bacterial, viral, or fungal infection.
- Subject who exhibits confusion or disorientation.
- Subject with any condition that would prevent adequate follow-up.
- Subject with a history of prior malignancy treated with systemic chemotherapy or
- Subject who has received two or more prior chemotherapy regimens for ovarian cancer.