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

NCT ID: NCT00176488

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2009-10-31

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:

• 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

epirubicin

Intervention Type: DRUG

Epirubicin (100 mg/m2) will be given on Day 1

vinorelbine

Intervention Type: DRUG

Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.

Interventions

epirubicin

Epirubicin (100 mg/m2) will be given on Day 1

Intervention Type: DRUG

vinorelbine

Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.

Intervention Type: DRUG

Other Intervention Names

epirubicin hydrochloride; vinorelbine ditartrate

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah L. Toppmeyer, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CINJ 040302

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000539565

Identifier Type: -

Identifier Source: org_study_id