Aromasin (Exemestane) in Patients With Recurrent or Refractory Stage II - IV Epithelial Ovarian Cancer

Inclusion Criteria: · Patients aged 18 years or older with a documented diagnosis of metastatic, stage II-IV, epithelial ovarian cancer and a histological/cytological confirmation of disease.· Patients must be oophorectomized or be post-menopausal (i.e. no menses within the last 12 months).· Patients should have objective evidence of measurable disease according to the modified RECIST guidelines. If no measurable disease is present, there must be a CA 125 level of ³ 30 U/mL in combination with non-measurable disease and/or ascites.· Patients may be designated:· First line - patients who have either refused or did not qualify for initial therapy with standard cis- or carboplatin + paclitaxel.· Refractory - progression while on chemotherapy, or relapse within 12 months of final chemotherapy (with a maximum of 2 lines of chemotherapy treatment)· Recurrent - relapse beyond 12 months of final chemotherapy (with a maximum of 2 lines of chemotherapy treatment)· In patients having received radiation therapy, at least 4 weeks must have passed subsequent to the cessation of the radiation therapy, prior to the baseline assessment in this study.· Patients with ECOG performance status of 0, 1 or 2 and a life expectancy of > 3 months.· Patients must have adequate haematological (WBC ³ 4000/mL, neutrophils ³ 2000/mL, platelets ³ 100,00/mL), hepatic (total bilirubin £ 1.5 x upper limit normal (ULN), AST/ALT £ 3 x ULN)) and renal (serum creatinine < 1.5 X ULN) organ functions.· Patients must give written informed consent signed prior to registration. Exclusion Criteria: Known hypersensitivity to exemestane· Participation in another clinical study within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy.· Patients with rapidly progressive disease for which hormonal therapy may not be indicated.· Concomitant malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin. Patients with other malignancies must be disease free for at least 5 years.· Patients with metastatic disease of the central nervous system, eg. Paraneoplastic cerebellar degeneration, metastatic medulloblastoma, intramedullary spinal cord involvement, etc.· Patients having received prior hormonal therapy for ovarian cancer including tamoxifen and aromatase inhibitors.· Patients with any other concurrent disease, which in the opinion of the Investigator, would make the patient inappropriate for entry into this study.· Patients who are not accessible for treatment and follow-up in scheduled hours at the participating center.