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Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
This study has been completed.
Study NCT00055861   Information provided by National Cancer Institute (NCI)
First Received: March 6, 2003   Last Updated: February 6, 2009   History of Changes

March 6, 2003
February 6, 2009
July 2002
 
 
 
Complete list of historical versions of study NCT00055861 on ClinicalTrials.gov Archive Site
 
 
 
Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
Phase II Study of Bevacizumab in Combination With Docetaxel in Patients With Advanced Breast Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: This phase II trial is to see if combining bevacizumab with docetaxel works in treating women who have locally advanced or metastatic breast cancer.

OBJECTIVES:

  • Determine the response rate in women with locally advanced or metastatic breast cancer treated with bevacizumab and docetaxel.
  • Determine the side effects of this regimen in these patients.
  • Correlate soluble activated endothelial cell markers and adhesion molecules, quantitation of tumor and/or endothelial cell apoptosis, and quantitation of microvessel density with clinical outcome in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on weeks 1 and 3 and docetaxel IV over 60 minutes on weeks 1, 2, and 3. Treatment repeats every 4 weeks for up to 12 courses in the absence of unacceptable toxicity or disease progression. After completion of 6 courses of combined treatment, patients with an ongoing response may receive bevacizumab alone in the absence of disease progression.

PROJECTED ACCRUAL: A total of 16-27 patients will be accrued for this study within 14-27 months.

Phase II
Interventional
Treatment, Open Label
Breast Cancer
  • Biological: bevacizumab
  • Drug: docetaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed breast cancer

    • Local-regional recurrences or metastatic disease
  • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No history or evidence of CNS disease (e.g., primary brain tumor or any brain metastases)
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No bleeding diathesis or coagulopathy

Hepatic

  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal
  • INR less than 1.5 (patients receiving warfarin)

Renal

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min
  • No baseline proteinuria

    • Patients with proteinuria of 1+ or greater at baseline are allowed provided 24-hour urinary protein is less than 500 mg

Cardiovascular

  • No symptomatic congestive heart failure
  • No cardiac arrhythmia
  • No uncontrolled hypertension
  • No history of stroke
  • No clinically significant peripheral artery disease
  • No arterial thromboembolic event within the past 6 months, including any of the following:

    • Transient ischemic attack
    • Cerebrovascular accident
    • Unstable angina
    • Myocardial infarction

Other

  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No seizures not controlled with standard medical therapy
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to study agents
  • No psychiatric illness or social situation that would preclude study compliance
  • No ongoing or active infection
  • No other concurrent uncontrolled illness
  • No non-healing wounds
  • No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Prior adjuvant chemotherapy allowed (up to 1 regimen for metastatic disease)

    • More than 6 months since prior taxane-containing adjuvant chemotherapy
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitocycin) and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 3 weeks since prior radiotherapy

Surgery

  • More than 28 days since prior major surgery or open biopsy
  • More than 7 days since prior fine needle aspirations other than in the breast
  • More than 7 days since prior placement of a vascular access device
  • No concurrent major surgical procedure

Other

  • No concurrent or recent full-dose oral or parenteral anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters)
  • No other concurrent investigational agents
  • No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory medications (known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00055861
 
CDR0000271359, OSU-0218, UCHSC-01239, NCI-2715
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Study Chair: Charles L. Shapiro, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
April 2004

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