SCCA Gynecologic Cancer Clinical Trials

Primary Objectives:

• Run-in Phase: Determine a dose regimen of EP-100 at which the initial benefit/risk of EP-100 combined with paclitaxel can be studied.
• Randomized Phase: Compare the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in patients with ovarian cancer.

Secondary Objectives:

• Randomized Phase: Quantify any significant changes in the safety profile of weekly paclitaxel alone compared to the doublet combination of paclitaxel with EP-100.
• Determine an initial benefit/risk profile for this new drug combination.

• Adult female with histologically confirmed epithelial ovarian carcinomas. Patient's tumor has been evaluated for expression of luteinizing hormone releasing hormone (LHRH) receptors before screening assessments.
• Reliable cancer treatment history documenting advanced disease in patients who are candidates for second- or third-line treatment, i.e., must have progressed during or recurred after treatment with a paclitaxel or platinum regimen.
• Evaluable disease based on criteria of the Gynecologic Intergroup Response Evaluation Criteria in Solid Tumors.
• Karnofsky performance status (KPS) ≥ 70%.

• 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 fr 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
• 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 QT Interval Corrected for Rate (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
• Life expectancy of less than 3 months
• Inadequate renal and liver functions and bone marrow reserve