Spots Global Cancer Trial Database for Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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Trial Identification
Brief Title: Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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
Study ID: NCT00407758
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
Rush University Medical Center, Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Evanston Northwestern Healthcare - Evanston Hospital, Evanston, Illinois, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
St. Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
Methodist Estabrook Cancer Center, Omaha, Nebraska, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
Contact Details
Name: Lydia Usha, MD
Affiliation: Rush University Medical Center
Role: STUDY_CHAIR
Name: Jean A. Hurteau, MD
Affiliation: NorthShore University HealthSystem
Role: STUDY_CHAIR
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