|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00274768 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well capecitabine works in treating patients with metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: capecitabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer |
| Estimated Enrollment: | 45 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive a fixed-dose of oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
Patients must have measurable disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
No clinically significant cardiac disease, including the following:
PRIOR CONCURRENT THERAPY:
Up to 3 prior cytotoxic regimens allowed for metastatic disease
No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)
Contacts and Locations| United States, Maryland | |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | |
| Annapolis, Maryland, United States, 21401 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Antonio C. Wolff, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00274768 History of Changes |
| Other Study ID Numbers: | J0425 CDR0000446286, P30CA006973, JHOC-J0425, JHOC-SKCCC-J0425, JHOC-IRB-04032502 |
| Study First Received: | January 10, 2006 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
stage IV breast cancer male breast cancer recurrent breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Capecitabine Fluorouracil Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |