Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT00132067
Eligibility Criteria:
Inclusion Criteria:
* 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
* No neuropathy (sensory and motor) \> grade 1
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No active infection requiring antibiotics
* No psychiatric illness or social situation that would preclude study compliance
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to vorinostat
* No other uncontrolled illness
* At least 4 weeks since prior immunotherapy for the malignancy
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for the malignancy and recovered
* No more than 2 prior cytotoxic chemotherapy regimens for recurrent or persistent disease
* No prior non-cytotoxic chemotherapy for recurrent or persistent disease, unless therapy was part of the primary treatment regimen
* No prior vorinostat
* At least 1 week since prior hormonal therapy for the malignancy
* Concurrent hormone replacement therapy allowed
* At least 4 weeks since prior radiotherapy for the malignancy and recovered
* No prior radiotherapy to \> 25% of bone marrow
* At least 4 weeks since prior surgery for the malignancy and recovered
* At least 4 weeks since other prior therapy for the malignancy
* At least 30 days since prior and no concurrent valproic acid
* Concurrent oral anticoagulants (i.e., warfarin) allowed provided there is increased vigilance with respect to monitoring PT/INR for the first 2 courses of study therapy or if there are any signs of bleeding
* No prior anticancer therapy that would preclude study participation
* No concurrent combination anti-retroviral therapy for HIV-positive patients
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00132067
Study Brief:
Protocol Section:
NCT00132067