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Bevacizumab Plus Docetaxel and Doxorubicin in Treating Patients With Previously Untreated Inflammatory or Locally Advanced Stage IIB or Stage III Breast Cancer
This study has been completed.
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00021086
  Purpose

RATIONALE: Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy such as docetaxel and doxorubicin use different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel and doxorubicin may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with docetaxel and doxorubicin in treating patients who have inflammatory or locally advanced stage IIB or stage III breast cancer that has not been previously treated with chemotherapy and/or radiation therapy.


Condition Intervention Phase
Breast Cancer
Biological: bevacizumab
Biological: filgrastim
Biological: pegfilgrastim
Drug: docetaxel
Drug: doxorubicin hydrochloride
Procedure: conventional surgery
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Pilot Study To Evaluate Angiogenesis After Treatment With Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) In Previously Untreated Patients With Inflammatory Breast Cancer or Locally Advanced Breast Cancer

Resource links provided by NLM:


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

Study Start Date: May 2001
Detailed Description:

OBJECTIVES:

  • Determine the effect of bevacizumab on angiogenic parameters, primary molecular parameters (endothelial apoptosis, endothelial proliferation, or tissue vascular endothelial growth factor), and dynamic MRI parameters in patients with previously untreated inflammatory or locally advanced breast cancer also treated with doxorubicin and docetaxel.
  • Determine the variability of primary molecular parameter values in patients treated with this regimen.
  • Correlate the primary parameters with clinical results and time to disease progression or recurrence in patients treated with this regimen.
  • Determine whether bevacizumab is associated with the production of a prothrombotic state in these patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 of courses 1-7. Patients also receive doxorubicin IV and docetaxel IV over 1 hour on day 1 and filgrastim (G-CSF) subcutaneously (SC) on days 2-11 or pegfilgrastim SC on day 2 of courses 2-7. Treatment repeats every 3 weeks for 7 courses in the absence of disease progression or unacceptable toxicity.

After completion of course 7, patients undergo reassessment of need for surgery.

After completion of any surgery, patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who are estrogen receptor and/or progesterone receptor positive may receive oral tamoxifen or anastrozole daily for 5 years beginning with course 8 of bevacizumab.

Patients are followed every 3 months for 1 year and then every 3-6 months for 2 years.

PROJECTED ACCRUAL: A total of 23 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 confirmed inflammatory or locally advanced stage IIB, IIIA, IIIB, or IIIC breast cancer

    • Previously untreated with chemotherapy and/or radiotherapy
  • No carcinomatous meningitis, brain metastases, or primary brain tumor
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN) (2 times ULN if Gilbert's disease is present and elevation is not related to tumor or other liver diseases)
  • AST/ALT no greater than 1.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • INR no greater than 1.50

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • 24-hour urine protein less than 500 mg
  • No prior primary renal disease except infection

Cardiovascular:

  • LVEF at least 50%
  • No New York Heart Association class II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No grade II or greater peripheral vascular disease within the past 12 months
  • No symptoms or signs of clinical heart failure
  • No uncontrolled hypertension

    • Systolic blood pressure greater than 160 mm Hg OR
    • Diastolic blood pressure greater than 100 mm Hg
  • No prior deep venous thrombosis
  • No arterial thromboembolic event (e.g., transient ischemic attack, cerebrobascular accident, unstable angina, or myocardial infarction) within the past 6 months
  • No history of stroke
  • No clinically significant peripheral artery disease
  • No other clinically significant cardiovascular disease

Pulmonary:

  • No pulmonary embolism

Neurologic:

  • See Disease Characteristics
  • No uncontrolled seizures
  • No clinical neuropathy grade 2 or greater
  • No other CNS disease

Other:

  • No active infection requiring IV antibiotics
  • No nonhealing wound or bone fracture within the past 28 days
  • No gastrointestinal bleeding within the past 6 months
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No hypersensitivity to products containing polysorbate 80 (Tween 80)
  • No known hypersensitivity to E. coli-derived products
  • No other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study entry
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • More than 28 days since prior major surgery

Other:

  • At least 10 days since prior full-dose oral or parenteral anticoagulants or chronic aspirin (greater than 325 mg/day)
  • No other concurrent antitumor therapy
  • No other concurrent investigational drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021086

Locations
United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Suparna B. Wedam, MD National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068746, NCI-01-C-0173, NCI-2772
Study First Received: July 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00021086     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
inflammatory breast cancer
male breast cancer

Additional relevant MeSH terms:
Skin Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Breast Neoplasms
Bevacizumab
Antibiotics, Antineoplastic
Angiogenesis Inhibitors
Doxorubicin
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009