Status:
COMPLETED
EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer
Lead Sponsor:
Esperance Pharmaceuticals Inc
Conditions:
Ovarian Cancer Recurrent
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 o...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01485848
Start Date
February 1 2012
End Date
May 1 2014
Last Update
June 10 2014
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
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