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EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer (ESP2011-002)

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ClinicalTrials.gov Identifier: NCT01485848
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : June 10, 2014
Information provided by (Responsible Party):
Esperance Pharmaceuticals Inc

Brief Summary:
Primary Objectives: o Run-in Phase: Determine a dose of EP-100 at which the initial benefit/risk of paclitaxel combined with EP-100 can be studied. o Randomized Phase: Compare the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in patients with ovarian cancer. Secondary Objectives: o Randomized Phase: Quantify any significant changes in the safety profile of weekly paclitaxel alone compared to the doublet combination of paclitaxel with EP-100. o Determine an initial benefit/risk profile for this new drug combination.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Recurrent Drug: EP-100 Drug: Paclitaxel Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: Paclitaxel
A single 1 hour intravenous infusion every week for 6 cycles (each cycle is 4 weeks)
Drug: EP-100
Pharmaceutical form:Solution Route of administration: Intravenous

Experimental: Paclitaxel + EP-100
Paclitaxel every week plus EP-100 twice weekly by 1 hour intravenous infusion for the first 3 weeks of each 4 week cycle for 6 cycles (each cycle is 4 weeks)
Drug: Paclitaxel
Pharmaceutical form:Solution Route of administration: Intravenous

Primary Outcome Measures :
  1. Number of patients with dose limiting toxicities (DLTs) at different doses [ Time Frame: Up to 30 weeks ]
  2. Overall Response Rate (ORR) [ Time Frame: Up to 30 weeks ]

Secondary Outcome Measures :
  1. Time to Progression (TTP) - Time [ Time Frame: Up to 18 months ]
  2. Progression-free Survival - Time [ Time Frame: Up to 18 months ]
  3. Overall Survival (OS) - Time [ Time Frame: Up to 18 months ]
  4. Duration of Response - Time [ Time Frame: Up to 18 months ]
  5. Number of Participants with Adverse Events [ Time Frame: Up to 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485848

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United States, California
Investigational Site Number 840001
Greenbrae, California, United States, 94904-2011
Investigational Site Number 840005
San Francisco, California, United States, 94115
United States, Kentucky
Investigational Site Number 840007
Louisville, Kentucky, United States, 40202
United States, Louisiana
Investigational Site Number 840010
Covington, Louisiana, United States, 70433
Investigational Site Number 840011
Shreveport, Louisiana, United States, 71103
United States, Montana
Investigational Site Number 840503
Bozeman, Montana, United States, 58715
United States, Ohio
Investigational Site Number 840004
Middletown, Ohio, United States, 45042
United States, Oregon
Investigational Site Number 840008
Portland, Oregon, United States, 97227-1191
United States, Texas
Investigational Site Number 840006
Houston, Texas, United States, 77030
United States, Washington
Investigational Site Number 840603
Kennewick, Washington, United States, 99336
Investigational Site Number 840103
Mount Vernon, Washington, United States, 98273
Investigational Site Number 840403
Seattle, Washington, United States, 98112
Investigational Site Number 840003
Seattle, Washington, United States, 98115
Investigational Site Number 840303
Tacoma, Washington, United States, 98415-0299
Investigational Site Number 840203
Wenatchee, Washington, United States, 98801
Sponsors and Collaborators
Esperance Pharmaceuticals Inc
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Responsible Party: Esperance Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT01485848    
Other Study ID Numbers: ACT12601
U1111-1124-2062 ( Other Identifier: UTN )
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action