Phase I Trial of Valproic Acid and Epirubicin in Solid Tumor Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Neoplasms, Advanced
Interventions
DRUG

Valproic acid

Beginning Dose, Level 1: 15 mg/kg/day.

DRUG

Epirubicin

Beginning Dose, Level 1: 75 mg/m\^2.

DRUG

5-fluorouracil

For breast cancer participants treated at MTD of Valproic acid and Epirubicin: 5-fluorouracil 500 mg/m\^2.

DRUG

Cyclophosphamide.

For breast cancer participants treated at MTD of Valproic acid and Epirubicin: cyclophosphamide 500 mg/m\^2.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Pfizer

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER