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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00132067 |
RATIONALE: Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well vorinostat works in treating patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer.
Condition | Intervention | Phase |
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Ovarian Cancer Peritoneal Cavity Cancer |
Drug: vorinostat |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Phase II Evaluation of Vorinostat, (SAHA, NCI-Supplied Agent [NSC #701852, IND #71976]) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma |
Study Start Date: | July 2005 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive oral vorinostat twice daily on days 1-14. Courses repeat every 21 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 22-60 patients will be accrued for this study within approximately 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Recurrent or persistent disease
Disease progression during OR persistent disease after completion of 1 prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or other organoplatinum compound) for primary disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Alabama | |
Comprehensive Cancer Center at University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Providence Saint Joseph Medical Center - Burbank | |
Burbank, California, United States, 91505 | |
United States, Connecticut | |
New Britain General Hospital | |
New Britain, Connecticut, United States, 06050 | |
United States, Delaware | |
Beebe Medical Center | |
Lewes, Delaware, United States, 19958 | |
CCOP - Christiana Care Health Services | |
Newark, Delaware, United States, 19713 | |
United States, Indiana | |
St. Vincent Indianapolis Hospital | |
Indianapolis, Indiana, United States, 46260 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Kentucky | |
Markey Cancer Center at University of Kentucky Chandler Medical Center | |
Lexington, Kentucky, United States, 40536-0293 | |
United States, Maryland | |
Union Hospital Cancer Center at Union Hospital | |
Elkton MD, Maryland, United States, 21921 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
St Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
Methodist Cancer Center at Methodist Hospital - Omaha | |
Omaha, Nebraska, United States, 68114 | |
United States, New Jersey | |
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | |
Voorhees, New Jersey, United States, 08043 | |
Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital | |
Teaneck, New Jersey, United States, 07666 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
David L. Rike Cancer Center at Miami Valley Hospital | |
Dayton, Ohio, United States, 45409 | |
Riverside Methodist Hospital Cancer Care | |
Columbus, Ohio, United States, 43214-3998 | |
United States, South Dakota | |
Rapid City Regional Hospital | |
Rapid City, South Dakota, United States, 57701 | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98104 | |
University Cancer Center at University of Washington Medical Center | |
Seattle, Washington, United States, 98195-6043 |
Study Chair: | Susan C. Modesitt, MD | Lucille P. Markey Cancer Center at University of Kentucky |
Study ID Numbers: | CDR0000439489, GOG-0170H |
Study First Received: | August 16, 2005 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00132067 |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer peritoneal cavity cancer |
Ovarian cancer Tooth Diseases Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Vorinostat Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms |
Dental Caries Recurrence Carcinoma Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Stomatognathic Diseases Endocrine Gland Neoplasms |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protective Agents Tooth Demineralization Pharmacologic Actions Adnexal Diseases |
Neoplasms Neoplasms by Site Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |