A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer
- Compare the objective response rate in women with advanced or metastatic breast cancer
treated with two dose levels of capecitabine.
- Compare the duration of response, time to progression, time to treatment failure,
survival, incidence of adverse events, and time to onset of the adverse experience in
patients treated with this drug.
- Compare the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Karnofsky performance status (70-80% vs 90-100%) and presence of hepatic metastases (yes vs
no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive lower-dose oral capecitabine twice daily on days 1-14.
- Arm II: Patients receive higher-dose oral capecitabine twice daily on days 1-14.
In both arms, courses repeat every 21 days in the absence of disease progression or
Quality of life is assessed at baseline, at the end of the third and sixth courses, and at
completion of therapy.
PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
study within 9 months.
Primary Purpose: Treatment
United States: Federal Government
|Logan Regional Hospital||Logan, Utah 84321|
|Oncology Clinic, P.C.||Colorado Springs, Colorado 80909|
|Charleston Hematology-Oncology, P.A.||Charleston, South Carolina 29403|
|Medical Oncology Care Associates||Orange, California 92668|
|Family Cancer Center||Collierville, Tennessee 38017|
|Maryland Hematology/Oncology Associates||Baltimore, Maryland 21236|
|Antelope Valley Hospital||Lancaster, California 93534|
|California Cancer Medical Center||West Covina, California 91790|
|Hematology Oncology Associates of theTreasure Coast - Port St. Lucie||Port Saint Lucie, Florida 34952|
|North Florida Cancer Center||St. Augustine, Florida 32086|