Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer - Full Text View

Sponsors and Collaborators:	Cancer Institute of New Jersey National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00176488

Purpose

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
Breast Cancer	Drug: epirubicin hydrochloride Drug: vinorelbine ditartrate Procedure: biopsy Procedure: gene expression analysis Procedure: immunohistochemistry staining method Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: protein expression analysis	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Vinorelbine Vinorelbine tartrate Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety [ Designated as safety issue: Yes ]
Efficacy [ Designated as safety issue: No ]
Response [ Designated as safety issue: No ]
Time to progression [ Designated as safety issue: No ]
Repression of microtubule-associated protein 4 after DNA damage [ Designated as safety issue: No ]
p53 expression changes [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	June 2003

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 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed stage IIB (T3, N0), IIIA, IIIB, or IV breast carcinoma
Original tumor must be available for analysis of p53 status
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
- Stage IIIB disease will be assessed by clinical exam (monitoring skin changes as well as tumor size)
No visceral crisis (lymphangitic pulmonary spread, or liver or marrow replacement sufficient to cause significant organ dysfunction)
No untreated CNS metastases
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
ECOG performance status 0-2
Life expectancy ≥ 8 weeks
Absolute neutrophil count ≥ 1,000/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 10 g/dL
Bilirubin normal
AST ≤ 3 times normal (≤ 5 times normal if liver metastases are present)
Creatinine ≤ 1.5 mg/dL
Ejection fraction ≥ lower limit of normal by MUGA scan or ECG
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception
No other malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
No pre-existing disease (i.e., cardiac, pulmonary, neurologic, or other disease) that the investigator judges to be clinically significant
No active infectious process, severe malnutrition, or intractable emesis

PRIOR CONCURRENT THERAPY:

Recovered from all prior therapy
At least 3 weeks since prior radiotherapy
At least 3 weeks since prior chemotherapy
- Maximum prior doxorubicin hydrochloride dose must be ≤ 300 mg/m² OR equivalent anthracycline (epirubicin hydrochloride) dose must be ≤ 540 mg/m² OR calculated total anthracycline dose must be ≤ 540 mg/m² (determined as 1.8 times total doxorubicin hydrochloride dose plus epirubicin hydrochloride dose)
No prior chemotherapy for metastatic disease
Prior adjuvant chemotherapy, radiotherapy, and/or hormonal therapy for breast cancer allowed
No concurrent radiotherapy except for brain metastases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176488

Locations

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

Sponsors and Collaborators

Cancer Institute of New Jersey

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Deborah L. Toppmeyer, MD

Cancer Institute of New Jersey

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000539565, CINJ-5034v2, CINJ-4423
Study First Received:	September 12, 2005
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00176488
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent breast cancer
stage II breast cancer
stage IIIA breast cancer

stage IIIB breast cancer
stage IV breast cancer
male breast cancer

Study placed in the following topic categories:

Vinorelbine
Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms

Vinblastine
Epirubicin
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009