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| Sponsor: | Montefiore Medical Center |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT00574587 |
Purpose
Chemotherapy plus trastuzumab (Herceptin) are standard treatments for breast cancer. There are circumstances where these treatments are given prior to surgery to reduce the size of the cancer and imptove the surgical outcome. In this trial, an oral drug called "vorinostat" will be given in combination with chemotherapy and trastuzumab. Vorinostat is a histone deacetylase (HDAC) inhibitor which is approved by the U.S. Food and Drug Administration for the treatment of a rare type of cancer involving the skin (cutaneous T cell lymphoma), but not for breast cancer. HDAC inhibitors work by unsilencing tumor suppressor genes and other genes in the cancer cells that are repressed; when the genes are turned back on by the drug, it leads to death of the cancer cells. HDAC inhibitors such as vorinostat have been shown to enhance the effects of chemotherapy and trastuzumab in experimental systems. The purpose of this trial is to determine the optimal dose of vorinostat to use in combination with standard chemotherapy plus trastuzumab, and to determine whether vorinostat enhances the effectiveness of standard chemotherapy plus trastuzumab.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Vorinostat Drug: Paclitaxel Drug: Trastuzumab Drug: Doxorubicin Drug: Cyclophosphamide Procedure: Mastectomy or Lumpectomy Drug: Post surgery therapy (Trastuzumab) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel and Trastuzumab Followed by Doxorubicin-Cyclophosphamide in Patients With Locally Advanced Breast Cancer |
| Estimated Enrollment: | 54 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | January 2010 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Vorinostat
Vorinostat 200 or 300 mg PO BID on days 1-3 of each weekly paclitaxel dose
Drug: Paclitaxel
Paclitaxel 80 mg/m2 weekly for 12 weeks
Drug: Trastuzumab
Part A: Trastuzumab 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose
Drug: Doxorubicin
Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks
Drug: Cyclophosphamide
Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks
Procedure: Mastectomy or Lumpectomy
Surgical excision of tumor from breast
Drug: Post surgery therapy (Trastuzumab)
Part D: After Surgical intervention Post Protocol Therapy- Trastuzumab 8 mg/kg as a loading dose, then 6 mg/kg every 3 weeks for a total of 14 doses
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lisa M Escobar-Peralta, BS | 718-904-2730 | lescobar@montefiore.org |
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Lisa M Escobar, BS 718-904-2730 lescobar@montefiore.org | |
| Principal Investigator: Joseph Sparano, MD | |
| Principal Investigator: | Joseph Sparano, MD | Montefiore Medical Center |
More Information
| Responsible Party: | Montefiore Medical Center ( Joseph Sparano, MD ) |
| Study ID Numbers: | NYCC1, 07-10-374 |
| Study First Received: | December 13, 2007 |
| Last Updated: | December 14, 2007 |
| ClinicalTrials.gov Identifier: | NCT00574587 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Vorinostat Neoadjuvant Chemotherapy |
|
Anticarcinogenic Agents Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Sensory System Agents Therapeutic Uses Trastuzumab Anti-Inflammatory Agents, Non-Steroidal Analgesics Alkylating Agents |
Breast Diseases Skin Diseases Vorinostat Mitosis Modulators Breast Neoplasms Enzyme Inhibitors Antimitotic Agents Protective Agents Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Paclitaxel Tubulin Modulators |