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Sponsored by: |
Pharmatech Oncology |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00026442 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 1 measurable lesion
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Antelope Valley Hospital | |
Lancaster, California, United States, 93534 | |
California Cancer Medical Center | |
West Covina, California, United States, 91790 | |
Medical Oncology Care Associates | |
Orange, California, United States, 92868 | |
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 |
Study ID Numbers: | CDR0000069030, PHARMATECH-XEL-154, PHARMATECH-20010330, ROCHE-PHARMATECH-XEL-154 |
Study First Received: | November 9, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00026442 |
Health Authority: | United States: Federal Government |
stage IV breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Capecitabine Skin Diseases Breast Neoplasms Breast Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |