A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
- Assess the efficacy of enzastaurin hydrochloride, in terms of 6-month progression-free
survival or objective tumor response, in patients with recurrent or persistent ovarian
epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
- Determine the duration of progression-free and overall survival of patients treated
with this regimen.
- Determine the effects of prognostic variables, including platinum sensitivity, initial
performance status, and age, in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days
2-28 of course 1. For all subsequent courses, patients receive enzastaurin hydrochloride
once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Frequency of patients with 6-month progression-free survival (PFS) or objective tumor response
Lydia Usha, MD
Rush University Medical Center
United States: Food and Drug Administration
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|Evanston Northwestern Healthcare - Evanston Hospital||Evanston, Illinois 60201-1781|
|Hinsdale Hematology Oncology Associates||Hinsdale, Illinois 60521|
|Rush University Medical Center||Chicago, Illinois 60612-3824|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Hulston Cancer Center at Cox Medical Center South||Springfield, Missouri 65807|
|St. Vincent Indianapolis Hospital||Indianapolis, Indiana 46260|
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Methodist Estabrook Cancer Center||Omaha, Nebraska 68114-4199|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|