EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer

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.