Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00407758 |
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.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: enzastaurin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 68 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Must have ≥ 1 target lesion to assess response
Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
Must meet any 1 of the following criteria for platinum-based therapy:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
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 | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
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 | |
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 | |
Rosenfeld Cancer Center at Abington Memorial Hospital | |
Abington, Pennsylvania, United States, 19001 | |
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 |
Investigator: | Jean A. Hurteau, MD | Evanston Northwestern Healthcare - Evanston Hospital |
Study ID Numbers: | CDR0000517318, GOG-0170J, LILLY-H6Q-MC-S025 |
Study First Received: | December 4, 2006 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00407758 |
Health Authority: | United States: Food and Drug Administration |
recurrent ovarian epithelial cancer peritoneal cavity cancer |
Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms |
Recurrence Carcinoma Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |