Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Completed · Phase 2
Conditions studied: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
In brief
This phase II trial is studying how well vorinostat works in treating patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer. 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.
Key facts
- Study ID
- NCT00132067
- Run by
- National Cancer Institute (NCI)
- People needed
- 60
- Starts
- 2005-10-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2019-07-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
- 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
- Initial treatment may have included high-dose, consolidation, noncytotoxic agents, or extended therapy administered after surgical or non-surgical assessment
- Treatment-free interval after completion of platinum-based chemotherapy must have been < 12 months
- Measurable disease, defined as ≥ 1 unidimensionally measurable target* lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
- No known brain metastases
- Performance status - GOG 0-1
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Able to take oral medication
- No bowel obstruction
- No persistent vomiting
- No parenteral feeding
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
Where it is running
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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