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Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
This study has been completed.
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00015938
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: filgrastim
Drug: vinorelbine ditartrate
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Filgrastim Docetaxel Vinorelbine Vinorelbine tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative, Stage IV Breast Cancer

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

Study Start Date: May 2001
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00015938

  Show 99 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Julie R. Gralow, MD Seattle Cancer Care Alliance
  More Information

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

Study ID Numbers: CDR0000068575, SWOG-S0102
Study First Received: May 6, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00015938  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Docetaxel
Vinorelbine
Skin Diseases
Breast Neoplasms
Vinblastine
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009