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

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: vinorelbine; Drug: docetaxel; Biological: filgrastim

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00015938

S0102 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

CDR0000068575

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

treatment

Experimental group

Description:

docetaxel and vinorelbine with filgrastim support

Treatment:

Drug: vinorelbine

Biological: filgrastim

Drug: docetaxel