Clinical trial NCT01485848: EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer Recurrent
Lead sponsor: Esperance Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of patients with dose limiting toxicities (DLTs) at different doses
timeFrame: Up to 30 weeks
measure: Overall Response Rate (ORR)
timeFrame: Up to 30 weeks
Secondary outcomes:
measure: Time to Progression (TTP) - Time
timeFrame: Up to 18 months
measure: Progression-free Survival - Time
timeFrame: Up to 18 months
measure: Overall Survival (OS) - Time
timeFrame: Up to 18 months
measure: Duration of Response - Time
timeFrame: Up to 18 months
measure: Number of Participants with Adverse Events
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Investigational Site Number 840001
state: California
city: San Francisco
country: United States
facility: Investigational Site Number 840005
state: California
city: Louisville
country: United States
facility: Investigational Site Number 840007
state: Kentucky
city: Covington
country: United States
facility: Investigational Site Number 840010
state: Louisiana
city: Shreveport
country: United States
facility: Investigational Site Number 840011
state: Louisiana
city: Bozeman
country: United States
facility: Investigational Site Number 840503
state: Montana
city: Middletown
country: United States
facility: Investigational Site Number 840004
state: Ohio
city: Portland
country: United States
facility: Investigational Site Number 840008
state: Oregon
city: Houston
country: United States
facility: Investigational Site Number 840006
state: Texas
city: Kennewick
country: United States
facility: Investigational Site Number 840603
state: Washington
city: Mount Vernon
country: United States
facility: Investigational Site Number 840103
state: Washington
city: Seattle
country: United States
facility: Investigational Site Number 840403
state: Washington
city: Seattle
country: United States
facility: Investigational Site Number 840003
state: Washington
city: Tacoma
country: United States
facility: Investigational Site Number 840303
state: Washington
city: Wenatchee
country: United States
facility: Investigational Site Number 840203
state: Washington
Study officials:
References: