Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of capecitabine in treating women who have advanced or metastatic breast cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer|
|Study Start Date:||November 2001|
- 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 unacceptable toxicity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026442
|United States, California|
|Antelope Valley Hospital|
|Lancaster, California, United States, 93534|
|Medical Oncology Care Associates|
|Orange, California, United States, 92868|
|California Cancer Medical Center|
|West Covina, California, United States, 91790|
|United States, Colorado|
|Oncology Clinic, P.C.|
|Colorado Springs, Colorado, United States, 80907|
|United States, Florida|
|Hematology Oncology Associates of theTreasure Coast - Port St. Lucie|
|Port Saint Lucie, Florida, United States, 34952|
|North Florida Cancer Center|
|St. Augustine, Florida, United States, 32086|
|United States, Maryland|
|Maryland Hematology/Oncology Associates|
|Baltimore, Maryland, United States, 21236|
|United States, South Carolina|
|Charleston Hematology-Oncology, P.A.|
|Charleston, South Carolina, United States, 29403|
|United States, Tennessee|
|Family Cancer Center|
|Collierville, Tennessee, United States, 38017|
|United States, Utah|
|Logan Regional Hospital|
|Logan, Utah, United States, 84341|
|Study Chair:||Sandy Marcus||Pharmatech Oncology|