Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00026442
- Lead Sponsor
- Pharmatech Oncology
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
🇺🇸Port Saint Lucie, Florida, United States
Maryland Hematology/Oncology Associates
🇺🇸Baltimore, Maryland, United States
Medical Oncology Care Associates
🇺🇸Orange, California, United States
Family Cancer Center
🇺🇸Collierville, Tennessee, United States
North Florida Cancer Center
🇺🇸St. Augustine, Florida, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
Charleston Hematology-Oncology, P.A.
🇺🇸Charleston, South Carolina, United States
Oncology Clinic, P.C.
🇺🇸Colorado Springs, Colorado, United States
Antelope Valley Hospital
🇺🇸Lancaster, California, United States
California Cancer Medical Center
🇺🇸West Covina, California, United States