|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| 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 |
| 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.
|
Drug: capecitabine
Given orally
Drug: docetaxel
Given IV
|
|
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
|
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| Study Chair: | Aman U. Buzdar, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000367239, PHARMANET-NO16853, PHARMANET-CRRI0403008, ROCHE-NO16853 |
| Study First Received: | May 14, 2004 |
| Last Updated: | February 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00083200 History of Changes |
| Health Authority: | Unspecified |
|
recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
|
Antimetabolites Docetaxel Capecitabine Skin Diseases |
Breast Neoplasms Breast Diseases Recurrence |
|
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Breast Neoplasms |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases |
