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| Sponsored by: |
PharmaNet |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00083200 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which dose of capecitabine is more effective when combined with docetaxel in treating breast cancer.
PURPOSE: This randomized phase II trial is studying two different doses of capecitabine when given together with docetaxel to compare how well they work in treating women with locally advanced or metastatic breast cancer that has not responded to previous anthracycline-based chemotherapy (such as daunorubicin, doxorubicin, or epirubicin).
| Condition | Intervention | Phase |
|
Breast Cancer |
Drug: capecitabine Drug: docetaxel |
Phase II |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| ChemIDplus related topics: | Docetaxel Capecitabine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | Open-Label Randomized Study of Two Different Dosing Regimens of Capecitabine in Combination With Intravenous Docetaxel (Q3W) in Patients With Metastatic Breast Cancer Whose Disease Has Progressed After Failure of Prior Anthracycline Containing Chemotherapy |
| Estimated Enrollment: | 440 |
| Study Start Date: | July 2003 |
| Arms | Assigned Interventions |
|
Arm I: Active Comparator
Patients receive standard-dose oral capecitabine twice daily on days 1-14 and docetaxel IV on day 1.
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Drug: capecitabine
Given orally
Drug: docetaxel
Given IV
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Arm II: Experimental
Patients receive lower-dose oral capecitabine twice daily on days 1-14 and docetaxel as in arm I.
|
Drug: capecitabine
Given orally
Drug: docetaxel
Given IV
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OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 440 patients (220 per treatment arm) will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations |
Show 35 Study Locations |
| PharmaNet |
| Study Chair: | Aman U. Buzdar, MD | M.D. Anderson Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
|
| Study ID Numbers: | CDR0000367239, PHARMANET-NO16853, PHARMANET-CRRI0403008, ROCHE-NO16853 |
| First Received: | May 14, 2004 |
| Last Updated: | August 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00083200 |
| Health Authority: | Unspecified |
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