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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

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer Recurrent

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Trial Information

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

Total duration of the study for each participant is 9 to 10 months, consisting of a 1 month
screening period, a 6 to 7 months treatment period, and a 30 day follow-up. All patients
with stable disease or who have achieved partial or complete response and for whom dosing
has been safe and reasonably well-tolerated may continue additional treatment cycles on the
same regimen. Any patient whose imaging assessment shows disease progression after receiving
at least two cycles of single agent weekly paclitaxel on ARM 1 may then be offered treatment
with the combination of EP-100 plus paclitaxel in the same dose regimen as ARM 2.

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with dose limiting toxicities (DLTs) at different doses

Outcome Time Frame:

Up to 30 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

October 2013

Related Keywords:

  • Ovarian Cancer Recurrent
  • Ovarian Neoplasms



Investigational Site Number 840001 Vallejo, California  94589
Investigational Site Number 840005 San Francisco, California  94117
Investigational Site Number 840004 Cincinnati, Ohio  45267-0542
Investigational Site Number 840006 San Antonio, Texas  78229
Investigational Site Number 840007 Paducah, Kentucky  42002
Investigational Site Number 840103 Mount Vernon, Washington  98273
Investigational Site Number 840403 Seattle, Washington  98112
Investigational Site Number 840003 Seattle, Washington  98115
Investigational Site Number 840010 Covington, Louisiana  70433
Investigational Site Number 840011 Shreveport, Louisiana  71103
Investigational Site Number 840503 Bozeman, Montana  58715
Investigational Site Number 840008 Portland, Oregon  97227-1191
Investigational Site Number 840603 Kennewick, Washington  99336
Investigational Site Number 840303 Tacoma, Washington  98415-0299
Investigational Site Number 840203 Wenatchee, Washington  98801