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

NCT00246103 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2017-02-23

No results posted yet for this study

Summary

This is a Phase I dose escalation trial with escalating doses of Valproic acid and one dose escalation step of epirubicin. VPA will be escalated starting at a dose that is recommended for use as an anti-convulsant or to treat migraine headaches. Epirubicin will be given by infusion on day 3 after the last dose of divalproex. The study will determine the highest dose that these two drugs can be given together and as part of a multidrug regimen with 5-fluorouracil and cyclophosphamide.

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Pfizer

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Pamela Munster, MD · H. Lee Moffitt Cancer Center and Research Institute

  • Adil Daud, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00246103 on ClinicalTrials.gov