Phase II trial to explore the efficacy of vorinostat and tamoxifen combined.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Vorinostat will be used to potentiate the effects of tamoxifen or overcome tamoxifen resistance. All patients will receive vorinostat at 400 mg by mouth (po) daily for 3 out of 4 weeks. Responses will be assessed after 2 cycles (8 weeks + 4 days).
Tamoxifen will be given once daily at 20 mg. Tamoxifen will be given continuously. Responses will be assessed after 2 cycles (8 weeks + 4 days).
University of California
San Francisco, California, United States
Bethesda Memorial Hospital Research Center
Boynton Beach, Florida, United States
M.D. Anderson of Orlando
Orlando, Florida, United States
Fawcett Memorial Hospital
Port Charlotte, Florida, United States
Number of Participants With Objective Response (OR)
The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained ≥ 4 weeks following initial documentation of objective response.
Time frame: 24 weeks
Time to Progression (TTP)
The median response duration in months. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Time frame: Up to 30 months
Number of Participants With Serious Adverse Events (SAEs)
Safety evaluation according to descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time frame: 4 years, 7 months
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Martin Memorial Cancer Center
Stuart, Florida, United States
Tallahassee Memorial HealthCare, Inc.
Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
St. Joseph's/Candler
Savannah, Georgia, United States