Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365599
Status:
COMPLETED
Last Update Posted:
2014-11-21
First Post:
2006-08-15
Brief Title:
Phase II Trial of SAHA Tamoxifen for Patients With Breast Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None