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| Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Collaborator: |
Merck |
| Information provided by (Responsible Party): | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00365599 |
Purpose
Phase II trial to explore the efficacy of vorinostat and tamoxifen combined.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: suberoylanilide hydroxamic acid Drug: tamoxifen citrate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
| Enrollment: | 43 |
| Study Start Date: | March 2006 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vorinostat and Tamoxifen
As outlined in Intervention descriptions
|
Drug: suberoylanilide hydroxamic acid
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 two cycles (8 weeks + 4 days).
Other Names:
Drug: tamoxifen citrate
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).
Other Names:
|
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:
Documentation of response and progression will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have cytologically/histologically documented locally advanced or metastatic breast cancer with either
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California | |
| San Francisco, California, United States, 94143 | |
| United States, Florida | |
| Bethesda Memorial Hospital Research Center | |
| Boynton Beach, Florida, United States, 33435 | |
| M.D. Anderson of Orlando | |
| Orlando, Florida, United States, 32806 | |
| Fawcett Memorial Hospital | |
| Port Charlotte, Florida, United States, 33949 | |
| Martin Memorial Cancer Center | |
| Stuart, Florida, United States, 34994 | |
| Tallahassee Memorial HealthCare, Inc. | |
| Tallahassee, Florida, United States, 32308 | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| St. Joseph's/Candler | |
| Savannah, Georgia, United States, 31405 | |
| Principal Investigator: | Susan Minton, D.O. | H. Lee Moffitt Cancer Center and Research Institute |
More Information
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00365599 History of Changes |
| Other Study ID Numbers: | MCC-14662 |
| Study First Received: | August 15, 2006 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Breast cancer Suberoylanilide hydroxamic acid (SAHA) Vorinostat Tamoxifen Anti-hormonal therapy Estrogen receptor positive |
Progesterone receptor positive Metastatic disease Aromatase inhibitors (Ais) Histone deacetylase (HDAC) inhibitors Selective estrogen receptor modulators(SERMS) |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Selective Estrogen Receptor Modulators Vorinostat Estrogen Receptor Modulators Histone Deacetylase Inhibitors Antineoplastic Agents, Hormonal |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |