Ovarian cancer is the most frequent cause of death due to gynecologic malignancies. For advanced stage disease, aggressive surgical debulking followed by platinum-based combination chemotherapy is the standard of care. As a result of recent GOG studies, paclitaxel and cisplatin therapy is considered to be the new standard of care in advanced ovarian cancer. Although the majority of patients demonstrate a complete clinical response, only 50% have a complete pathological response. Doxorubicin has a broad spectrum of antineoplastic action and a correspondingly widespread degree of clinical use. High doses of this drug must generally be avoided because of potential cardiotoxic effects. A liposomal encapsulation would enhance its efficacy. On 4/19/96, FDA's Oncology Drug Advisory Committee recommended approval of Topotecan for advanced ovarian cancer after failure of initial or subsequent chemotherapy. The objective of this study is to compare the efficacy and safety of Doxil/Caelyx versus Topotecan HCL in advanced ovarian cancer patients. Patients will be treated for up to one year with either a one-hour infusion of Doxil/Caelyx every 28 days or Topotecan as a 30-minute infusion for five consecutive days every 21 days.
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