Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176488
Status:
TERMINATED
Last Update Posted:
2017-03-23
First Post:
2005-09-12
Brief Title:
Epirubicin and Vinorelbine in Treating Patients With Stage II Stage III or Stage IV Breast Cancer
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
A Phase II Trial of Sequential EpirubicinVinorelbine in Patients With Advanced Breast Cancer
Status:
TERMINATED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Competing studies
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 epirubicin and vinorelbine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving epirubicin together with vinorelbine may kill more tumor cells
PURPOSE This phase II trial is studying how well giving epirubicin together with vinorelbine works in treating patients with stage II stage III or stage IV breast cancer
PURPOSE This phase II trial is studying how well giving epirubicin together with vinorelbine works in treating patients with stage II stage III or stage IV breast cancer
Detailed Description:
OBJECTIVES
Assess the efficacy of sequential use of epirubicin hydrochloride followed by vinorelbine ditartrate in patients with stage IIB IIIA IIIB or IV breast cancer
Measure the biological response to this regimen in sequential tumor biopsies and peripheral mononuclear cells from these patients
Correlate tumor response with changes in the gene expression of microtubule-associated protein 4
OUTLINE Patients receive epirubicin hydrochloride IV on day 1 and vinorelbine ditartrate IV over 6-10 minutes on days 3 and 17 Patients also receive filgrastim G-CSF subcutaneously on days 4-14 or pegfilgrastim IV on day 4
For patients with stage IIB T3 N0 IIIA or IIIB disease treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity For patients with stage IV disease treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and after course 1 for research studies Patients with accessible tumor for biopsy undergo sequential biopsies and core needle biopsies at baseline and after course 1 Tumor tissue samples are used for determination of p53 status by western blot analysis immunohistochemistry and DNA sequencing Microtubule-associated protein 4 p53 and p21WAF1 expression is analyzed by western blotting
After completion of study treatment patients are followed for 1 month
PROJECTED ACCRUAL A total of 46 patients will be accrued for this study
Assess the efficacy of sequential use of epirubicin hydrochloride followed by vinorelbine ditartrate in patients with stage IIB IIIA IIIB or IV breast cancer
Measure the biological response to this regimen in sequential tumor biopsies and peripheral mononuclear cells from these patients
Correlate tumor response with changes in the gene expression of microtubule-associated protein 4
OUTLINE Patients receive epirubicin hydrochloride IV on day 1 and vinorelbine ditartrate IV over 6-10 minutes on days 3 and 17 Patients also receive filgrastim G-CSF subcutaneously on days 4-14 or pegfilgrastim IV on day 4
For patients with stage IIB T3 N0 IIIA or IIIB disease treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity For patients with stage IV disease treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and after course 1 for research studies Patients with accessible tumor for biopsy undergo sequential biopsies and core needle biopsies at baseline and after course 1 Tumor tissue samples are used for determination of p53 status by western blot analysis immunohistochemistry and DNA sequencing Microtubule-associated protein 4 p53 and p21WAF1 expression is analyzed by western blotting
After completion of study treatment patients are followed for 1 month
PROJECTED ACCRUAL A total of 46 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CINJ 040302 | OTHER | Cancer Institute of New Jersey | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |