EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer (ESP2011-002)

Inclusion criteria:

• Adult patients with histologically confirmed epithelial ovarian carcinomas; these will include primary peritoneal and fallopian tube carcinomas. Patient's tumor shown to be positive for the LHRH-receptors by standardized immunocytochemistry performed at the study's central laboratory.
• Reliable cancer treatment history documenting advanced disease in patients who have progressed during or recurred after treatment with a paclitaxel and/or platinum regimen for advanced disease.
• Evaluable disease based on criteria of the Gynecologic Intergroup Response Evaluation Criteria in in Solid Tumors.
• Karnofsky performance status >/= 70%.

Exclusion criteria:

• Significant cardiac disease.
• Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
• Pregnant or nursing women.
• Treatment with radiation therapy or investigational therapy within 4 weeks prior to Day 1. Had received chemotherapy prior to study entry equivalent to 3 to 5 half-lives of that chemotherapy agent or 4 weeks prior to study entry (whichever is shorter) with resolution of any side effects from that previous therapy (6 weeks for nitrosoureas or Mitomycin C.)
• Subjects with known central nervous system (CNS) metastases, either previously treated or current.
• Disease-free and off therapy for any other cancer within 5 years, except for adequately treated basal cell or squamous cell skin cancer or cervical intraepithelial neoplasia (CIN).
• Had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1. o Had minor surgery (superficial incisions unlikely to obscure bleeding or infections) within 2 weeks prior to Day 1.
• Potentially life-threatening disease (hypercalcemia, spinal cord compression) whose disease may progress acutely during therapy.
• Unwilling or unable to comply with procedures required in this protocol.
• Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• Susceptibility to histamine release.
• Chronic treatment with corticosteroids.
• Baseline QTc exceeding 450 msec (by Bazett's formula) and/or patients receiving class 1A or class III antiarrythmic agents.
• Serious nonmalignant disease.
• Subjects who are currently receiving any other investigational agent.
• Inadequate renal and liver functions and bone marrow reserve.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.