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Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer
This study has been completed.
Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00017394
  Purpose

RATIONALE: Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in treating patients who have stage IV breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab
Drug: vinorelbine ditartrate
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Vinorelbine Vinorelbine tartrate Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Bevacizumab in Combination With Vinorelbine in Stage IV Breast Cancer

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

Study Start Date: March 2001
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the complete and partial response rates in patients with stage IV breast cancer treated with concurrent bevacizumab and vinorelbine.
  • Determine the side effects of this regimen in these patients.
  • Determine the time to disease progression in patients treated with this regimen.
  • Determine the time on study (a reflection of time to progression, treatment-related side effects, and patient preference) of patients treated with this regimen.
  • Assess urine protein/creatinine ratio and serum complement levels as screening measures for renal injury in patients treated with bevacizumab.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage IV breast cancer

    • Patients without pathologic or cytologic confirmation of metastatic disease must have unequivocal evidence of metastasis by physical exam or radiologic study
  • Must meet 1 of the following criteria:

    • Received 1 or 2 prior conventional chemotherapy regimens for metastatic disease
    • Relapsed within 1 year after adjuvant chemotherapy and no prior chemotherapy for metastatic disease
  • At least 1 unidimensionally measurable lesion, meeting 1 of the following criteria:

    • At least 20 mm by conventional techniques
    • At least 10 mm by spiral CT scan
  • No CNS metastases by CT scan or MRI within the past 6 weeks
  • No prior or concurrent primary CNS tumor on physical exam
  • Disease progression after bone marrow or peripheral blood stem cell transplantation allowed
  • HER2-positive tumors allowed if previously treated with trastuzumab (Herceptin)
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • More than 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Hemoglobin at least 9 g/dL
  • Platelet count at least 100,000/mm^3
  • No prior bleeding diathesis or coagulopathy

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN
  • INR no greater than 1.5

Renal:

  • Creatinine less than 2 mg/dL
  • Urine protein no greater than +1 by dipstick OR
  • Urine protein less than 500 mg by 24-hour urine collection

Cardiovascular:

  • LVEF at least 50%
  • No prior stroke
  • No New York Heart Association class II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication, including atrial fibrillation requiring systemic anticoagulation
  • No grade II or greater peripheral vascular disease within the past year
  • No clinically significant peripheral artery disease
  • No deep vein thrombosis or embolism within the past 5 years
  • No arterial thromboembolic event within the past 6 months, including any of the following:

    • Transient ischemic attack
    • Cerebrovascular accident
    • Unstable angina
    • Myocardial infarction
  • No other significant cardiovascular disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No evidence of seizures not controlled with standard medical therapy
  • No prior allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study
  • Prior mild infusion reaction to trastuzumab allowed
  • No serious nonhealing wound, ulcer, or bone fracture
  • No significant traumatic injury within the past 4 weeks
  • No other concurrent illness (such as active infection) that would require active treatment or preclude study
  • No psychiatric illness or social situation that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior bevacizumab
  • No other prior experimental angiogenesis inhibitors
  • At least 2 weeks since prior trastuzumab and recovered
  • Concurrent epoetin alfa or filgrastim (G-CSF) allowed

Chemotherapy:

  • See Disease Characteristics
  • At least 2 weeks since prior chemotherapy and recovered
  • No prior vinorelbine
  • No more than 2 prior conventional chemotherapy regimens for metastatic breast cancer

Endocrine therapy:

  • Prior hormonal therapy allowed

Radiotherapy:

  • At least 1 week since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • At least 4 weeks since prior major surgical procedure or open biopsy
  • At least 1 week since prior fine-needle aspiration except in the breast
  • No concurrent major surgical procedure

Other:

  • Recovered from the toxic effects of any prior therapy
  • At least 10 days since prior oral or parenteral anticoagulants (e.g., heparin or warfarin) except to maintain the patency of permanent, indwelling central venous catheter
  • At least 10 days since prior thrombolytic agents
  • No chronic aspirin therapy greater than 325 mg per day or nonsteroidal anti-inflammatory medications that inhibit platelet function
  • No concurrent COX-2 inhibitors that inhibit platelet function
  • No other concurrent investigational or commercial agents or therapies for the malignancy
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent ketoconazole, zidovudine, or macrolide antibiotics
  • No concurrent oral or parenteral anticoagulants except to maintain patency of permanent, indwelling central venous catheter
  • No concurrent thrombolytic agent
  • Concurrent bisphosphonates allowed
  • Concurrent celecoxib or rofecoxib allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017394

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Harold J. Burstein, MD, PhD Dana-Farber Cancer Institute
  More Information

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

Study ID Numbers: CDR0000068685, DFCI-01013, NCI-2716
Study First Received: June 6, 2001
Last Updated: January 10, 2009
ClinicalTrials.gov Identifier: NCT00017394  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
male breast cancer

Study placed in the following topic categories:
Vinorelbine
Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms
Vinblastine
Bevacizumab
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009