Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.
Primary Peritoneal Cavity Cancer
Drug: enzastaurin hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma|
- Frequency of patients with 6-month progression-free survival (PFS) or objective tumor response [ Designated as safety issue: No ]
- Frequency and severity of adverse effects as measured by CTCAE v3.0 [ Designated as safety issue: Yes ]
- Duration of PFS and overall survival [ Designated as safety issue: No ]
- Prognostic factors, including platinum sensitivity, initial performance status, and age [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407758
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Decatur Memorial Hospital Cancer Care Institute|
|Decatur, Illinois, United States, 62526|
|Evanston Northwestern Healthcare - Evanston Hospital|
|Evanston, Illinois, United States, 60201-1781|
|Hinsdale Hematology Oncology Associates|
|Hinsdale, Illinois, United States, 60521|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Indiana|
|St. Vincent Indianapolis Hospital|
|Indianapolis, Indiana, United States, 46260|
|United States, Michigan|
|CCOP - Grand Rapids|
|Grand Rapids, Michigan, United States, 49503|
|United States, Missouri|
|Hulston Cancer Center at Cox Medical Center South|
|Springfield, Missouri, United States, 65807|
|United States, Nebraska|
|Methodist Estabrook Cancer Center|
|Omaha, Nebraska, United States, 68114|
|United States, North Carolina|
|Blumenthal Cancer Center at Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28232-2861|
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|Rosenfeld Cancer Center at Abington Memorial Hospital|
|Abington, Pennsylvania, United States, 19001|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center|
|Reading, Pennsylvania, United States, 19612-6052|
|United States, Washington|
|University Cancer Center at University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|Study Chair:||Lydia Usha, MD||Rush University Medical Center|
|OverallOfficial:||Jean A. Hurteau, MD||NorthShore University HealthSystem Research Institute|