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

NCT ID: NCT01485848

Last Updated: 2014-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-05-31

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.

Conditions

Ovarian Cancer Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel

A single 1 hour intravenous infusion every week for 6 cycles (each cycle is 4 weeks)

Group Type: ACTIVE_COMPARATOR

EP-100

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

Paclitaxel + EP-100

Paclitaxel every week plus EP-100 twice weekly by 1 hour intravenous infusion for the first 3 weeks of each 4 week cycle for 6 cycles (each cycle is 4 weeks)

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

Interventions

EP-100

Pharmaceutical form:Solution Route of administration: Intravenous

Intervention Type: DRUG

Paclitaxel

Pharmaceutical form:Solution Route of administration: Intravenous

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Esperance Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

U1111-1124-2062

Identifier Type: OTHER

Identifier Source: secondary_id

ACT12601

Identifier Type: -

Identifier Source: org_study_id