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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00176488 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: epirubicin hydrochloride Drug: vinorelbine ditartrate Genetic: gene expression analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: immunologic technique Other: laboratory biomarker analysis Procedure: biopsy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced Breast Cancer |
Estimated Enrollment: | 46 |
Study Start Date: | June 2003 |
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease, defined as any lesion that can be accurately measured in ≥ 1 dimension with longest diameter ≥ 20 mm using conventional techniques OR ≥ 10 mm with spiral CT scan
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 3 weeks since prior chemotherapy
United States, New Jersey | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 |
Principal Investigator: | Deborah L. Toppmeyer, MD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000539565, CINJ-5034v2, CINJ-4423 |
Study First Received: | September 12, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00176488 History of Changes |
Health Authority: | Unspecified |
recurrent breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IV breast cancer male breast cancer |
Skin Diseases Breast Neoplasms Vinblastine Breast Cancer, Male Antimitotic Agents Epirubicin Recurrence |
Anti-Bacterial Agents Vinorelbine Breast Neoplasms, Male Tubulin Modulators Antineoplastic Agents, Phytogenic Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Mitosis Modulators Breast Neoplasms Vinblastine Antimitotic Agents Antibiotics, Antineoplastic Epirubicin |
Pharmacologic Actions Neoplasms Neoplasms by Site Vinorelbine Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Breast Diseases |