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

Sponsor
Esperance Pharmaceuticals Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01485848
Collaborator
(none)
49
Enrollment
15
Locations
2
Arms
26.9
Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Feb 1, 2012
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of patients with dose limiting toxicities (DLTs) at different doses [Up to 30 weeks]

  2. Overall Response Rate (ORR) [Up to 30 weeks]

Secondary Outcome Measures

  1. Time to Progression (TTP) - Time [Up to 18 months]

  2. Progression-free Survival - Time [Up to 18 months]

  3. Overall Survival (OS) - Time [Up to 18 months]

  4. Duration of Response - Time [Up to 18 months]

  5. Number of Participants with Adverse Events [Up to 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigational Site Number 840001 Greenbrae California United States 94904-2011
2 Investigational Site Number 840005 San Francisco California United States 94115
3 Investigational Site Number 840007 Louisville Kentucky United States 40202
4 Investigational Site Number 840010 Covington Louisiana United States 70433
5 Investigational Site Number 840011 Shreveport Louisiana United States 71103
6 Investigational Site Number 840503 Bozeman Montana United States 58715
7 Investigational Site Number 840004 Middletown Ohio United States 45042
8 Investigational Site Number 840008 Portland Oregon United States 97227-1191
9 Investigational Site Number 840006 Houston Texas United States 77030
10 Investigational Site Number 840603 Kennewick Washington United States 99336
11 Investigational Site Number 840103 Mount Vernon Washington United States 98273
12 Investigational Site Number 840403 Seattle Washington United States 98112
13 Investigational Site Number 840003 Seattle Washington United States 98115
14 Investigational Site Number 840303 Tacoma Washington United States 98415-0299
15 Investigational Site Number 840203 Wenatchee Washington United States 98801

Sponsors and Collaborators

  • Esperance Pharmaceuticals Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Esperance Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT01485848
Other Study ID Numbers:
  • ACT12601
  • U1111-1124-2062
First Posted:
Dec 6, 2011
Last Update Posted:
Jun 10, 2014
Last Verified:
Jun 1, 2014
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Paclitaxel

Study Results

No Results Posted as of Jun 10, 2014