Spots Global Cancer Trial Database for Phase II Trial of SAHA & Tamoxifen for Patients With Breast Cancer
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Trial Identification
Brief Title: Phase II Trial of SAHA & Tamoxifen for Patients With Breast Cancer
Official Title: 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.
Study ID: NCT00365599
Conditions
Study Description
Brief Summary: Phase II trial to explore the efficacy of vorinostat and tamoxifen combined.
Detailed Description: 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).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
Contact Details
Name: Susan Minton, D.O.
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR
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