Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Breast Cancer

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID: NCT01010854
Run by: University of California, San Francisco
People needed: 6
Starts: 2008-12-10
Expected to finish: 2011-07-29
Last updated by the study team: 2018-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed diagnosis of breast cancer
Patients must have "locally advanced" adenocarcinoma of the breast:
tumors > 2 cm without lymph node involvement (negative sentinel lymph node mapping)
tumors > 2 cm with lymph node involvement (either by positive sentinel lymph node mapping or FNA of palpable lymph node)
tumors of any size that show extension to the chest wall or skin, including edema, ulceration, or satellite skin nodules
inflammatory carcinoma (stage IIIB) that is amenable to surgery
tumors of any size associated with ipsilateral internal mammary nodes (stage IIIB)
tumors of any size associated with ipsilateral supraclavicular lymph nodes (IIIC) without other evidence of systemic metastases
patients may have bilateral breast cancer if both breasts are assessible for response
Age >18 years
Because no dosing or adverse event data are currently available on the use of VPA in combination with FEC100 in patients <18 years of age, children are excluded from this study
ECOG performance status 0 or 1 (Karnofsky >80%)
Patients must have normal organ and marrow function as defined below:
leukocytes >3,000/mcL
absolute neutrophil count >1,500/mcL
platelets >100,000/mcL
total bilirubin within 1.5 x normal institutional limits
AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
Creatinine within normal institutional limits
VPA has been associated with neural tube defects in the developing human fetus, for this reason and because FEC100 used in this trial are also known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Participating men must use condoms while on study and for at least 3 months after the trial has ended. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

Patients may not have had any prior chemotherapy within the last 2 years
Patients may not have been exposed to prior anthracyclines
Patients may not be receiving any other investigational agents
Patients with known brain metastases are excluded
History of allergic reactions attributed to compounds of similar chemical or biologic composition to VPA or FEC100.
Patients with known congestive heart disease or LVEF fractions of <50 % (past or current), patients with known ventricular arrhythmias
Patients taking VPA as an anti-seizure agent or for any other indications
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Due to the teratogenic effects of VPA and FEC100, pregnant or lactating women are excluded from the study.

Where it is running

University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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