Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-04 @ 8:23 PM
Study NCT ID:
NCT00274768
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2006-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Capecitabine in Treating Patients With Metastatic Breast Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Study Overview
Official Title:
Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
PURPOSE: This phase II trial is studying how well capecitabine works in treating patients with metastatic breast cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine.
Secondary
* Determine the clinical benefit, time to treatment failure (TTF), safety, and toxicity profile of this regimen in these patients.
* Determine the pharmacokinetics (PK) and pharmacogenetics in these patients.
* Correlate pharmacodynamic effects of this drug with toxicity and response in these patients.
* Determine compliance and adherence to this regimen and correlate with PK parameters in these patients.
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.
Primary
* Determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine.
Secondary
* Determine the clinical benefit, time to treatment failure (TTF), safety, and toxicity profile of this regimen in these patients.
* Determine the pharmacokinetics (PK) and pharmacogenetics in these patients.
* Correlate pharmacodynamic effects of this drug with toxicity and response in these patients.
* Determine compliance and adherence to this regimen and correlate with PK parameters in these patients.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA006973 | NIH | None | https://reporter.nih.gov/quic… | View |
| JHOC-J0425 | OTHER | SKCCC | View | |
| JHOC-SKCCC-J0425 | OTHER | SKCCC | View | |
| JHOC-IRB-04032502 | OTHER | SKCCC | View |