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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Esperance Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT01485848
First received: December 2, 2011
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Ovarian Cancer Recurrent
Drug: EP-100
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Esperance Pharmaceuticals Inc:

Primary Outcome Measures:
  • Number of patients with dose limiting toxicities (DLTs) at different doses [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: Yes ]
  • Overall Response Rate (ORR) [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Progression (TTP) - Time [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Progression-free Survival - Time [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) - Time [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Duration of Response - Time [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: Up to 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: February 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485848

Locations
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 840003
Seattle, Washington, United States, 98115
Investigational Site Number 840403
Seattle, Washington, United States, 98112
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
  More Information

No publications provided

Responsible Party: Esperance Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT01485848     History of Changes
Other Study ID Numbers: ACT12601, U1111-1124-2062
Study First Received: December 2, 2011
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014