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

NCT01010854 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CC# 087515
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

breast cancer; advanced; local

Outcome Measures

Primary Outcomes (1)

• Pathologic Response at Definitive Surgery

  after 4 cycles of therapy

Secondary Outcomes (1)

• Clinical Response Based on Tumor Measurement

  after 4 cycles of therapy

Study Arms (1)

VPA FEC100

EXPERIMENTAL

Valproic Acid with FEC100

Drug: VPA FEC100

Interventions

VPA FEC100 DRUG

oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)

VPA FEC100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pamela Munster, MD
• Organization: University of California, San Francisco

clinicaltrials@ucsf.edu

877-827-3222

Study Officials

• Pamela Munster, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 10, 2009
• Study Start: December 10, 2008
• Primary Completion: December 12, 2010
• Study Completion: July 29, 2011
• Last Updated: March 9, 2018
• Results First Posted: March 9, 2018

Record last verified: 2018-02

Locations

US (1)