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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00041067 |
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 trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as filgrastim, may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: filgrastim Biological: trastuzumab Drug: docetaxel Drug: vinorelbine ditartrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer |
Estimated Enrollment: | 90 |
Study Start Date: | September 2002 |
OBJECTIVES:
OUTLINE: This is a pilot, multicenter study.
Patients receive docetaxel IV over 1 hour on day 1, filgrastim (G-CSF) subcutaneously on days 2-21, vinorelbine IV over 6-10 minutes on days 8 and 15, and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. If docetaxel and vinorelbine are discontinued due to unacceptable toxicity, patients may continue to receive trastuzumab. If trastuzumab is discontinued due to unacceptable toxicity, patients may continue to receive chemotherapy with G-CSF support.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18-22.5 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Joseph J. Kash, MD | Edward Hospital Cancer Center |
Study ID Numbers: | CDR0000069440, SWOG-S0215 |
Study First Received: | July 8, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00041067 History of Changes |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer |
Docetaxel Vinorelbine Skin Diseases Tubulin Modulators Trastuzumab Breast Neoplasms |
Vinblastine Antimitotic Agents Antineoplastic Agents, Phytogenic Breast Diseases Recurrence |
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Mitosis Modulators Breast Neoplasms Vinblastine Antimitotic Agents Pharmacologic Actions Docetaxel |
Neoplasms Neoplasms by Site Vinorelbine Therapeutic Uses Tubulin Modulators Trastuzumab Antineoplastic Agents, Phytogenic Breast Diseases |