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Sponsored by: |
H. Lee Moffitt Cancer Center and Research Institute |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00437801 |
The drugs FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) are the standard way to treat your type of cancer. In this study, we will add another drug called Valproic Acid (VPA) to see whether this makes the treatment better. The addition of Valproic Acid to chemotherapy has been studied in about 65 subjects with cancer and was found to be safe and tolerable.
The results of a Phase I study of Valproic Acid and FEC100 in subjects with cancer that spreads has led us to believe that this combination is better than just the standard treatment alone. We are now testing the combination in a study with subjects who have either a large tumor or many lymph nodes involved. In addition to the treatment, a main goal of the study is to find out which subjects will benefit from this combination.
Subjects with breast cancer that has not spread will be asked to participate. Valproic acid will begin on day 1 and will be given for 6 doses, on day 3, the FEC100 regimen will be infused. A biopsy of the tumor will be mandatory on day 3 of cycle 1. A treatment cycle will last for three weeks and the treatment will be given for 4 cycles. Subjects will have to come to the center on day 1 and 3 of each cycle. In addition to the standard tests that will be done during the chemotherapy, two more teaspoons of blood will be taken in cycle 1 and cycle 4 to see how the drug is distributed in the blood stream.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Epirubicin Drug: 5-fluorouracil Drug: cyclophosphamide Drug: Valproic Acid |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Locally Advanced Breast Cancer |
Estimated Enrollment: | 55 |
Study Start Date: | January 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Mira (Mensura) Lacevic, MD 813-745-8304 lacevicm@moffitt.usf.edu | |
Contact: Connie Schmitt 813-745-8948 CONNIE.SCHMITT@MOFFITT.ORG | |
Principal Investigator: Pamela N Munster, MD | |
Sub-Investigator: W. Bradford Carter, MD | |
Sub-Investigator: Charles Cox, MD | |
Sub-Investigator: Christine Laronga, MD |
Principal Investigator: | Pamela N Munster, MD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | MCC-14947, IRB#105070 |
Study First Received: | February 19, 2007 |
Last Updated: | February 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00437801 |
Health Authority: | United States: Institutional Review Board |
breast cancer FEC100 valproic acid Histone deacetylases |
Skin Diseases Fluorouracil Breast Neoplasms Cyclophosphamide |
Valproic Acid Epirubicin Breast Diseases |
Antimetabolites Neurotransmitter Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Alkylating Agents Tranquilizing Agents |
Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists GABA Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Central Nervous System Agents Anticonvulsants |