Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Breast Cancer
Status:
Terminated
Trial end date:
2011-07-29
Target enrollment:
Participant gender:
Summary
The drugs FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) are one of the approved
options to treat Locally Advanced or Primary Metastatic Breast Cancer. In this study, the
investigators 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. Valproic Acid is approved by the
Food and Drug Administration (FDA) for the treatment of seizures, mood swings, and migraine
headaches. It is not currently approved for cancer, which is why the investigators are
conducting this study.
The results of a Phase I study of Valproic Acid and FEC100 in subjects with cancer that has
spread has led the investigators to believe that this combination is better than just the
standard treatment alone. The investigators are now testing the combination in a study with
subjects who have either a large tumor, many lymph nodes involved or patients whose tumor has
spread. In addition to the treatment, a main goal of the study is to find out which subjects
will benefit from this combination. In the Phase I trial the investigators noticed that while
this combination appears to make the chemotherapy more effective, it did not appear to cause
more side effects induced by the chemotherapy.
Phase:
Phase 2
Details
Lead Sponsor:
University of California, San Francisco
Collaborator:
H. Lee Moffitt Cancer Center and Research Institute