Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | September 12, 2005 | ||||
Last Updated Date | June 16, 2011 | ||||
Start Date ICMJE | June 2003 | ||||
Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE |
The overall goal of this proposal is to conduct a Phase II clinical trial of sequential epirubicin/vinorelbine to determine the biological and clinical activity of this regimen in patients with locally advanced or metastatic breast cancer. | ||||
Change History | Complete list of historical versions of study NCT00176488 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer | ||||
Official Title ICMJE | A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced Breast Cancer | ||||
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. |
||||
Detailed Description | OBJECTIVES:
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. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE |
|
||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Enrollment ICMJE | 31 | ||||
Completion Date | |||||
Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
Gender | Both | ||||
Ages | 21 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00176488 | ||||
Other Study ID Numbers ICMJE | CDR0000539565, P30CA072720, CINJ 040302, 0220034423 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Deborah L. Toppmeyer, Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | ||||
Study Sponsor ICMJE | University of Medicine and Dentistry New Jersey | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
|
||||
Information Provided By | University of Medicine and Dentistry New Jersey | ||||
Verification Date | June 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |