Overview
EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer
Status:
Completed
Completed
Trial end date:
2014-05-01
2014-05-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Esperance Pharmaceuticals IncTreatments:
Albumin-Bound Paclitaxel
Paclitaxel
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.