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

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.

Key Facts

Interventions

Conditions

Eligibility

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.

Outcome Measures

Locations