S0102: Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Lenograstim; Vinblastine; Vinorelbine

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