Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Ovarian Cancer

Inclusion Criteria

• •Histologic diagnosis of ovarian cancer or primary peritoneal carcinoma
• •Stage III or IV disease
• •One and only one prior cytotoxic chemotherapy regimen which must have included a platinum agent
• •Platinum resistant disease, defined as documented progression within six months of completion of first line therapy
• •Adult (18 years of age or older) patients
• •Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)
• •Serum creatinine less than 2.0 mg/dL
• •Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values
• •ECOG performance status of 0 - 2
• •Bidimensional measurable or clinically evaluable disease
• •Patients who have signed an IRB / Ethics Committee approved informed consent
• •Life expectancy at least 12 weeks
• •Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)
• •Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)