Phase II trial to explore the efficacy of vorinostat and tamoxifen combined. Tamoxifen will be given once daily, continuously. Vorinostat will be given daily for 3 out of 4 weeks (a cycle). Responses will be assessed (restaged) after 2 cycles and toxicities will be captured continuously. Eligible patients will receive treatment in consecutive 4-week cycles, until progression of disease or unacceptable toxicity. Patients will be followed for evaluation of safety for at least 30 days after the last dose of the study drug.~Tests will be obtained pre-and post vorinostat treatment and correlated with plasma levels of vorinostat at the time of tumor biopsy and vorinostat doses; the tests will consist of:~Patient history~Physical exam (including height and weight)~Toxicity assessment~Pharmacokinetic (PK) sample~Tumor fine needle aspirate (FNA)~Peripheral Blood Mononuclear Cells (PBMC)~Standard labs and Chemistry Profile~Carcinoembryonic antigen (CEA), cancer antigen (Ca) 15-3, Ca 125 (If clinically indicated)~Pregnancy Test~Computed tomography (CT) scans, and magnetic resonance imaging (MRI)~Documentation of response and progression will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).
Phase II trial to explore the efficacy of vorinostat and tamoxifen combined.