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Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
This study has been completed.
Study NCT00015938   Information provided by National Cancer Institute (NCI)
First Received: May 6, 2001   Last Updated: February 6, 2009   History of Changes

May 6, 2001
February 6, 2009
May 2001
 
 
 
Complete list of historical versions of study NCT00015938 on ClinicalTrials.gov Archive Site
 
 
 
Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative, Stage IV Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combining docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.

OBJECTIVES:

  • Determine the 1-year survival of women with HER-2-negative stage IV breast cancer treated with docetaxel, vinorelbine, and filgrastim (G-CSF).
  • Determine the response rate (both complete and partial response) and time to progression in patients treated with this regimen.
  • Determine the qualitative and quantitative toxic effects of this regimen in this patient population.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1, vinorelbine IV over 6-10 minutes on days 8 and 15, and filgrastim (G-CSF) subcutaneously on days 2-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 4-5 months.

Phase II
Interventional
Treatment, Open Label
Breast Cancer
  • Biological: filgrastim
  • Drug: docetaxel
  • Drug: vinorelbine ditartrate
 
 

*   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 confirmed stage IV carcinoma of the breast
  • HER-2 negative

    • 0 or 1+ DAKO (2+ DAKO allowed if fluorescence in situ hybridization [FISH] negative)
    • Weak or no staining on immunohistochemistry test
    • No amplification by FISH
  • No effusions or ascites as only site of disease
  • No brain or CNS disease or metastases
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Zubrod 0-2

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT or SGPT no greater than 1.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Not specified

Other:

  • No clinically significant pre-existing grade 2 or greater motor or sensory peripheral neuropathy unless due to cancer
  • No known sensitivity to E. coli-derived proteins
  • No prior severe hypersensitivity reaction to drugs formulated with polysorbate 80
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy other than 1 prior adjuvant or neoadjuvant chemotherapy program for primary disease
  • At least 6 months since prior chemotherapy
  • Prior adjuvant anthracycline allowed
  • No prior taxanes (docetaxel or paclitaxel)

Endocrine therapy:

  • Prior adjuvant hormonal therapy for metastatic disease allowed
  • No concurrent hormonal therapy

Radiotherapy:

  • At least 3 weeks since prior radiotherapy

Surgery:

  • At least 2 weeks since prior surgery and recovered
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00015938
 
CDR0000068575, SWOG-S0102
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Julie R. Gralow, MD Seattle Cancer Care Alliance
National Cancer Institute (NCI)
February 2004

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