NCT00245050View on ClinicalTrials.gov

Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

April 30, 2008

Study Completion Date

September 30, 2011

Conditions
Breast CancerDrug/Agent Toxicity by Tissue/OrganEndometrial CancerFallopian Tube CancerOvarian CancerPeritoneal Cavity Cancer
Interventions
DIETARY_SUPPLEMENT

pyridoxine hydrochloride

Arm I: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral pyridoxine twice 100 mg daily on days 1-28.

DRUG

Placebo

Arm II: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.

DRUG

doxorubicin HCL liposome

IV, 40mg/m2

Trial Locations (8)

44024

Geauga Regional Hospital, Cleveland

44060

Lake/University Ireland Cancer Center, Cleveland

44130

Southwest General Health Center, Cleveland

44143

University Suburban Health Center, Cleveland

44145

UHHS Westlake Medical Center, Cleveland

44708

Mercy Cancer Center at Mercy Medical Center, Cleveland

UHHS Chagrin Highlands Medical Center, Cleveland

44106-5065

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Case Comprehensive Cancer Center

OTHER

NCT00245050 - Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer | Biotech Hunter | Biotech Hunter