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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091195 |
RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die. FR901228 may also stop the growth of ovarian epithelial or peritoneal cavity cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with recurrent ovarian epithelial or peritoneal cavity cancer.
Condition | Intervention | Phase |
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Ovarian Cancer Peritoneal Cavity Cancer |
Drug: romidepsin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Single Agent Depsipeptide (FK228) In Recurrent, Platinum Sensitive Adeno-Carcinoma Of The Ovary Or Peritoneum |
Study Start Date: | September 2004 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 22-51 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:
Histologically or cytologically confirmed primary ovarian epithelial or peritoneal cavity cancer
Achieved a complete response after initial prior platinum-containing (cisplatin or carboplatin) chemotherapy regimen (e.g., conventional-dose therapy, high-dose therapy, consolidation therapy, or extended therapy after surgical or nonsurgical assessment)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, North Carolina | |
CCOP - Southeast Cancer Control Consortium | |
Goldsboro, North Carolina, United States, 27534-9479 | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1030 | |
High Point Regional Hospital | |
High Point, North Carolina, United States, 27262 |
Study Chair: | Brigitte E. Miller, MD | Wake Forest University |
Study ID Numbers: | CDR0000384614, CCCWFU-83403, NCI-6321 |
Study First Received: | September 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00091195 History of Changes |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer peritoneal cavity cancer |
Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Romidepsin Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Recurrence |
Carcinoma Genital Diseases, Female Anti-Bacterial Agents Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Adenocarcinoma Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Romidepsin Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Antibiotics, Antineoplastic Abdominal Neoplasms |
Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Therapeutic Uses Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |