Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) in Combination With Tamoxifen for Patients With Advanced Breast Cancer Who Have Failed Prior Anti-hormonal Therapy.
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
- 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).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Susan Minton, D.O.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|Martin Memorial Cancer Center||Stuart, Florida 34995-9010|
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|
|Fawcett Memorial Hospital||Port Charlotte, Florida 33952|
|University of California||San Francisco, California 94108|
|Bethesda Memorial Hospital Research Center||Boynton Beach, Florida 33435|
|M.D. Anderson of Orlando||Orlando, Florida 32806|
|Tallahassee Memorial HealthCare, Inc.||Tallahassee, Florida 32308|
|St. Joseph's/Candler||Savannah, Georgia 31405|