Status:
UNKNOWN
A Phase I/II Study of Paclitaxel Plus Carboplatin Plus Vorinostat in Recurrent Ovarian Cancer
Lead Sponsor:
Herlev Hospital
Collaborating Sponsors:
Odense University Hospital
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
TITLE:A Phase II non-comparative study of paclitaxel plus carboplatin in combination with Vorinostat in patients with advanced, recurrent epithelial ovarian cancer. INDICATION:Second-line treatment of...
Eligibility Criteria
Inclusion
- Histological verified epithelial carcinoma derived from ovarian, peritoneum or uterine tubes
- Women ≥18 years old.
- ECOG performance status ≤2.
- Expected duration of life \>3 months.
- Previous treatment regimen containing platinum and paclitaxel.
- Platinum and paclitaxel sensitive tumor, defined as a minimum of 6 months from cessation of treatment until disease progression.
- Measurable or assessable lesion.Patients having increased CA-125 as the only sign of recurrence are also eligible.
- Normal organ functions defined by the following values:
- Absolute neutrophil count (ANC) ≥1,500/µL Platelets ≥100,000/µL Hemoglobin ≥9.0g/dL or \> 5.7 mmol/L CA125 0-35 Glomerular filtration rate (GFR) measured using Cr-EDTA clearance GFR ≥50 mL/minute (not corrected for body surface area) Serum Total bilirubin ≤1.5 times the 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.
- Signed informed consent before inclusion.
- Prepared to appear for the planned follow-up visits and capable of handling toxicity.
Exclusion
- Patients treated with an experimental drug within the last 4 weeks before inclusion, and patients who receive other concomitant anticancer treatment.
- Patients having an active infection, or who have received intravenous antibacterial or antifungal medicine within the last 2 weeks before inclusion.
- 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.
- 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.
- Previous treatment with more than first-line chemotherapy.
- Progression during treatment with first-line chemotherapy containing platin/paclitaxel or disease progression less than 6 months after treatment cessation.
- 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, congestive heart failure.
- Previous treatment for, or other concomitant malignant disease within the last 5 years, except for curative treated carcinoma in situ cervical cancer or basal cell carcinoma.
- Previous severe allergic reactions in connection with carboplatin, paclitaxel or agents within the histone deacetylase inhibitor group.
- 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 hyper sensitive reactions with regards to products containing Cremophor EL (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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00772798
Start Date
June 1 2007
End Date
June 1 2009
Last Update
October 15 2008
Active Locations (1)
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1
Department of Oncology R
Odense, Denmark, DK-5000 C