Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer

This study has been terminated.
(Competing studies)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier:
NCT00176488
First received: September 12, 2005
Last updated: September 18, 2013
Last verified: September 2013

September 12, 2005
September 18, 2013
June 2003
October 2009   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00176488 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To assess the efficacy of the sequential use of a DNA damaging drug (epirubicin) followed by a vinca alkaloid (vinorelbine) in the treatment of breast cancer.
  • To measure the biological response to epirubicin and vinorelbine administered in patients with breast cancer in sequential tumor biopsies and peripheral blood mononuclear cells.
  • To correlate tumor response with changes in the gene expression of Microtubule Associated Protein 4 (MAP4).
Not Provided
Not Provided
 
Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced 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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: epirubicin
    Epirubicin (100 mg/m2) will be given on Day 1
    Other Name: epirubicin hydrochloride
  • Drug: vinorelbine
    Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
    Other Name: vinorelbine ditartrate
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.
Interventions:
  • Drug: epirubicin
  • Drug: vinorelbine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00176488
CDR0000539565, P30CA072720, CINJ 040302
No
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
University of Medicine and Dentistry New Jersey
National Cancer Institute (NCI)
Principal Investigator: Deborah L. Toppmeyer, MD Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP