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

Completed · Phase 2

Conditions studied: Ovarian Cancer Recurrent

In brief

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.

Key facts

Study ID

NCT01485848

Run by

Esperance Pharmaceuticals Inc

People needed

49

Starts

2012-02-01

Expected to finish

2014-05-01

Last updated by the study team

2014-06-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840001 — Greenbrae, California, United States
• Investigational Site Number 840005 — San Francisco, California, United States
• Investigational Site Number 840007 — Louisville, Kentucky, United States
• Investigational Site Number 840010 — Covington, Louisiana, United States
• Investigational Site Number 840011 — Shreveport, Louisiana, United States
• Investigational Site Number 840503 — Bozeman, Montana, United States
• Investigational Site Number 840004 — Middletown, Ohio, United States
• Investigational Site Number 840008 — Portland, Oregon, United States
• Investigational Site Number 840006 — Houston, Texas, United States
• Investigational Site Number 840603 — Kennewick, Washington, United States
• Investigational Site Number 840103 — Mount Vernon, Washington, United States
• Investigational Site Number 840403 — Seattle, Washington, United States
• Investigational Site Number 840003 — Seattle, Washington, United States
• Investigational Site Number 840303 — Tacoma, Washington, United States
• Investigational Site Number 840203 — Wenatchee, Washington, United States

Full record on ClinicalTrials.gov

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