Statement: the primary trial results indicate that the Recommended Phase II Dose for Vorinostat, as Assessed by NCI Common Terminology Criteria for Adverse Events, is 300 mg.
Primary_evidence: Outcome Measurement:    Recommended Phase II Dose as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)   Dose-limiting toxcities (DLT) were defined as grade 3-4 febrile neutropenia, thrombocytopenia and non-hemtological toxicity attributed to therapy (nausea, vomiting and diarrhea would be considered dose limiting only if not adequately controlled with therapy). Any toxicity occurring during cycle 1 that resulted in dose reduction of vorinostat or paclitaxel or failure to complete all protocol specificed doses in the first cycle was also considered a DLT   Time frame: 28 days Results 1:    Arm/Group Title: Phase I   Arm/Group Description: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.   All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.   Overall Number of Participants Analyzed: 6   Measure Type: Number   Unit of Measure: mg  300