SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

April 30, 2000

Primary Completion Date

December 31, 2002

Study Completion Date

October 31, 2003

Conditions
Breast Cancer
Interventions
DRUG

doxorubicin hydrochloride

Patients receive doxorubicin IV continuously over 72 hours on days 1-3 of course 1. For all subsequent courses, patients receive doxorubicin as in course 1. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.

DRUG

semaxanib

For all subsequent courses, after course 1 patients SU5416 IV over 1 hour twice weekly (on days 1 and 4) beginning on week 2 of course 2. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.

PROCEDURE

conventional surgery

Patients undergo a modified radical mastectomy.

RADIATION

radiation therapy

Patients undergo radiotherapy to the chest wall and regional lymph nodes.

DRUG

tamoxifen

Patients with estrogen or progesterone receptor positive disease receive oral tamoxifen for 5 years after radiotherapy.

Trial Locations (1)

44106-5065

Ireland Cancer Center at University Hospitals Case Medical Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Case Comprehensive Cancer Center

OTHER

NCT00005822 - SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer | Biotech Hunter | Biotech Hunter