EP-100, a Novel LHRH Receptor-Targeted, Membrane-Disrupting Peptide, Plus Paclitaxel Versus Paclitaxel Alone for Refractory or Recurrent Ovarian Cancer: A Phase II, Randomized, Multicenter Trial

Inclusion Criteria

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.