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SCCA Gynecologic Cancer Clinical Trials

EP-100 Plus Paclitaxel Versus Paclitaxel Alone for Ovarian Cancer (7685)
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
Status Conditions Phase Study ID
Closed Ovarian Cancer Recurrent Phase II 7685
NCT01485848
Summary

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.

Investigator
Renata R. Urban, MD
Location    
SCCA Network 206-288-7232 Refer Patient
Bozeman Deaconess Cancer Center, Bozeman, MT 406-585-5070  
Multicare Health System, Tacoma WA 253-403-5265  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Columbia Basin Hematology & Oncology, Kennewick, WA 509-783-4637  
Group Health 206-225-7893  
Eligibility Criteria (must meet the following to participate in this study)
  • 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%.
Exclusions (conditions that would prevent participation in this study)
  • 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 
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Last Updated
May 12, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.