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Complete title: EP-100, a Novel LHRH Receptor-Targeted Membrane-Disruptive Peptide, plus Paclitaxel® versus Paclitaxel® alone for Refractory or Recurrent Ovarian Cancer: a Phase II, Randomized, Multi-Center Trial
|Research Study Number||7685|
|Principal Investigator||Renata Urban|
Research Study Description
-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.
-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.
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Female
- 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%.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Other exclusion criteria may apply.
Gynecological Cancer; Ovarian Cancer; Solid Tumors
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