Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced Breast Cancer|
- Efficacy of the Sequential Use of a DNA Damaging Drug (Epirubicin) Followed by a Vinca Alkaloid (Vinorelbine) in the Treatment of Breast Cancer. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Biological Response to Epirubicin and Vinorelbine Administered in Patients With Breast Cancer in Sequential Tumor Biopsies and Peripheral Blood Mononuclear Cells. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Correlate Tumor Response With Changes in the Gene Expression of Microtubule Associated Protein 4 (MAP4). [ Time Frame: 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: Sequential epirubicin/vinorelbine
For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
Epirubicin (100 mg/m2) will be given on Day 1
Other Name: epirubicin hydrochlorideDrug: vinorelbine
Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
Other Name: vinorelbine ditartrate
- 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 p21/WAF1 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176488
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Deborah L. Toppmeyer, MD||Rutgers Cancer Institute of New Jersey|