A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Frequency of patients with 6-month progression-free survival (PFS) or objective tumor response
No
Lydia Usha, MD
Study Chair
Rush University Medical Center
United States: Food and Drug Administration
CDR0000517318
NCT00407758
November 2006
Name | Location |
---|---|
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 |