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Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: January 4, 2002   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
North Central Cancer Treatment Group
National Cancer Institute of Canada
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028990
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, 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. It is not yet known whether paclitaxel works better with or without bevacizumab in treating breast cancer.

PURPOSE: This randomized phase III trial is to see if paclitaxel works better with or without bevacizumab in treating patients who have locally recurrent or metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Biological: bevacizumab
Drug: paclitaxel
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Paclitaxel Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Randomized Phase III Tial Of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) As First-Line Therapy For Locally Recurrent or Metastatic Breast Cancer

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

Study Start Date: December 2001
Detailed Description:

OBJECTIVES:

  • Compare the time to treatment failure in patients with locally recurrent or metastatic breast cancer treated with paclitaxel with or without bevacizumab.
  • Compare the objective response rate, duration of response, overall survival, and time to progression in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease-free interval (no more than 24 months vs more than 24 months), number of metastatic sites (less than 3 vs 3 or more), treatment with prior adjuvant chemotherapy (yes vs no), and estrogen receptor status (positive vs negative vs unknown). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 followed by bevacizumab IV over 30-90 minutes on days 1 and 15.
  • Arm II: Patients receive paclitaxel as in arm I. In both arms, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and on day 1 of weeks 17 and 33.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 316-650 patients (158-325 per treatment arm) will be accrued for this study within 31 months.

  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 adenocarcinoma of the breast
  • Locally recurrent disease that is not amenable to surgical resection with curative intent OR
  • Metastatic disease
  • No HER-2-overexpressing (3+) breast cancer unless previously treated with trastuzumab (Herceptin)

    • Unknown HER-2 status allowed provided herceptin-based therapy inappropriate or not indicated
  • No prior or radiologic evidence of CNS metastases, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by head CT scan or MRI
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

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

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN for known liver involvement)
  • PT/PTT no greater than 1.5 times normal
  • INR no greater than 1.5 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL
  • No proteinuria by dipstick urinalysis
  • Trace proteinuria allowed
  • Proteinuria less than 500 mg by 24-hour urine collection if proteinuria at least 1+ by urinalysis

Cardiovascular:

  • No clinically significant cardiovascular disease
  • No myocardial infarction within the past 12 months
  • No unstable angina
  • No prior deep vein thrombosis
  • No grade 2 or greater peripheral vascular disease
  • No uncontrolled congestive heart failure
  • No uncontrolled hypertension (systolic blood pressure greater than 170 mmHg and diastolic blood pressure greater than 95 mm Hg)
  • No prior cerebrovascular accident

Pulmonary:

  • No prior pulmonary embolism

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective non-hormonal contraception
  • No history of seizures
  • No non-healing wound or fracture
  • No hypersensitivity to paclitaxel, Cremophor EL, Chinese hamster ovary cell products, or other recombinant human antibodies
  • No active infection requiring parenteral antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • No prior chemotherapy for locally recurrent or metastatic breast cancer
  • At least 12 months since prior adjuvant or neoadjuvant taxane therapy
  • At least 3 weeks since prior adjuvant chemotherapy

Endocrine therapy:

  • At least 3 weeks since prior hormonal therapy for locally recurrent or metastatic breast cancer

Radiotherapy:

  • At least 3 weeks since prior radiotherapy
  • No prior radiotherapy to only site of disease
  • No concurrent local radiotherapy for pain control or life-threatening situations (e.g, superior vena cava syndrome, spinal cord compression, or CNS metastases)

Surgery:

  • At least 4 weeks since prior major surgical procedure except placement of vascular access device or breast biopsy
  • At least 7 days since prior minor surgical procedure, including placement of an access device or fine needle aspiration

Other:

  • At least 10 days since prior anticoagulant therapy (low-dose anticoagulant therapy to maintain patency of a vascular access device allowed)
  • At least 10 days since prior and no concurrent daily aspirin (more than 325 mg/day) or other non-steroidal anti-inflammatory medication known to inhibit platelet function
  • No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028990

  Show 30 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
National Cancer Institute of Canada
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
Study Chair: Kathy Miller, MD Indiana University Melvin and Bren Simon Cancer Center
Investigator: Robin Zon, MD Elkhart General Hospital
Study Chair: Edith A. Perez, MD Mayo Clinic
Study Chair: Tamara N. Shenkier, MD British Columbia Cancer Agency
Study Chair: Melody A. Cobleigh, MD Rush University Medical Center
  More Information

Additional Information:
Publications:
Schneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, Flockhart DA, Hancock B, Davidson N, Gralow J, Dickler M, Perez EA, Cobleigh M, Shenkier T, Edgerton S, Miller KD; ECOG 2100. Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol. 2008 Oct 1;26(28):4672-8.
Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007 Dec 27;357(26):2666-76.
Wagner LI, Wang M, Miller K, et al.: Health-related quality of life among patients with metastatic breast cancer receiving paclitaxel versus paclitaxel plus bevacizumab: results from the Eastern Cooperative Oncology Group (ECOG) study E2100. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-5078, S239, 2006.
Miller KD, Wang M, Gralow J, et al.: A randomized phase III trial of paclitaxel versus paclitaxel plus bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer: a trial coordinated by the Eastern Cooperative Oncology Group (E2100). [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-3, 2005.
Miller KD. E2100: a phase III trial of paclitaxel versus paclitaxel/bevacizumab for metastatic breast cancer. Clin Breast Cancer. 2003 Feb;3(6):421-2. No abstract available.
Gray R, Giantonio BJ, O'Dwyer PJ, et al.: The safety of adding angiogenesis inhibition into treatment for colorectal, breast, and lung cancer: the Eastern Cooperative Oncology Group's (ECOG) experience with bevacizumab (anti-VEGF). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-825, 2003.

Study ID Numbers: CDR0000069156, ECOG-2100, NCCTG-E2100, CAN-NCIC-MAC3, NSABP-E2100
Study First Received: January 4, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00028990     History of Changes
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:
Skin Diseases
Breast Neoplasms, Male
Paclitaxel
Tubulin Modulators
Breast Neoplasms
Antimitotic Agents
Bevacizumab
Breast Cancer, Male
Angiogenesis Inhibitors
Antineoplastic Agents, Phytogenic
Breast Diseases
Recurrence

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

ClinicalTrials.gov processed this record on May 07, 2009