Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse (CALYPSO)

Inclusion Criteria: Patients aged > 18 Histologically proven diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors Measurable disease (Response Evaluation Criteria in Solid Tumor [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria) or with histologically proven diagnosis of relapse Disease in progression > 6 months after a first or second platinum-based line. Patients should have previously received a taxane derivative. ECOG performance status < 2 Life expectancy of at least 12 weeks Adequate bone marrow, renal, and hepatic function Exclusion Criteria: Ovarian tumors of low malignant potential Non-epithelial ovarian or mixed epithelial/non-epithelial tumors Previous radiotherapy Prior diagnosis of malignancy Bowel obstruction, sub-occlusive disease, or presence of symptomatic brain metastases Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 1 History of congestive heart failure (New York Heart Association [NYHA] classification > 2), history of myocardial infarction within the last 6 months, or history of atrial or ventricular arrhythmias Severe active infection Severe hypersensitivity to products containing Cremophor EL and/or to compounds chemically related to paclitaxel, carboplatin or Caelyx Fertile women not using adequate contraceptive methods Pregnant or breast feeding women