Table 1.
Inclusion and exclusion criteria.
Inclusion Criteria | Exclusion Criteria |
---|---|
Histological-verified epithelial ovarian, peritoneal, or fallopian tube carcinoma. | Patients treated with an experimental drug within the last 4 weeks before inclusion, and patients who received other concomitant anticancer treatments. |
Women ≥ 18 years. | Patients having an active infection or who have received intravenous antibacterial or antifungal medicine within the last 2 weeks before inclusion. |
ECOG performance status ≤ 2. | Previous treatment with more than first-line chemotherapy. |
Expected duration of life > 3 months. | Patients previously treated with an HDAC inhibitor. Patients who have been treated with Valproate for convulsions can be included; however, only if the treatment has taken place > 30 days before inclusion. |
Previous treatment regimen containing platinum and paclitaxel. | Patients treated with steroid who are not stabilized on a firm dose equivalent to a maximum of 10 mg prednisolone per day for the last 4 weeks before inclusion. |
Platinum and paclitaxel sensitive tumor, defined as a minimum of 6 months from cessation of treatment until disease progression. | Progression during treatment with first-line chemotherapy containing platinum/paclitaxel or disease progression less than 6 months after treatment cessation. |
Measurable or assessable lesion. Patients having increased CA-125 as the only sign of recurrence are also eligible. | Concomitant serious and/or non-controllable medical condition such as non-controllable infection (including HIV-infected patients), hypertension, ischemic heart disease, myocardial infarction within the last 6 months, or congestive heart failure. |
Signed informed consent before inclusion. | Previous treatment for or another concomitant malignant disease within the last 5 years, except for curative-treated carcinoma in situ cervical cancer, or basal cell carcinoma. |
Prepared to appear for the planned follow-up visits and capable of handling toxicity. | Previous severe allergic reactions in connection with carboplatin, paclitaxel, or agents within the histone deacetylase inhibitor group. |
Normal organ functions * | Women of child-bearing age. Women must have undergone surgical removal of the ovaries or be post-menopausal with no menstruation during the previous year. |
Peripheral neuropathy ≥ grade 2, unless this is due to a medical condition. | |
Patients with history of severe hypersensitive reactions with regards to products containing cyclosporine or K-vitamin) and/or patients with known hypersensitivity towards agents chemically connected to paclitaxel, carboplatin, or vorinostat. | |
Patients with known cerebral metastases or clinical signs of cerebral metastases. |
* Defined by the following values: Absolute neutrophil count ≥ 1500/μL; platelets ≥ 100,000/μL; hemoglobin ≥ 9.0 g/dL or >5.7 mmol/L; CA125 0–35; glomerular filtration rate (GFR) measured using Cr-EDTA clearance ≥ 50 mL/minute; serum total bilirubin ≤ 1.5 times the upper level of normal (ULN); AST (SGOT) and ALT (SGPT) ≤ 2.5 times the ULN; alkaline phosphatase ≤ 5.0 times the ULN; prothrombin time (PT) ≤ 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation; partial thromboplastin time (PTT) ≤ 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation.