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An Open-Label Phase II Study of Navelbine (Vinorelbine Tartrate) and Taxotere (Docetaxel) as First-Line Therapy for Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

An Open-Label Phase II Study of Navelbine (Vinorelbine Tartrate) and Taxotere (Docetaxel) as First-Line Therapy for Metastatic Breast Cancer

OBJECTIVES: I. Determine the response rate in women with metastatic breast cancer treated
with vinorelbine and docetaxel. II. Determine the time to disease progression, time to
treatment failure, response duration, and survival in this patient population treated with
this regimen.

OUTLINE: This is a multicenter study. Patients receive vinorelbine IV on days 1 and 8, and
docetaxel IV over 1 hour on day 1 only. Treatment continues every 21 days in the absence of
disease progression or unacceptable toxicity. Patients are followed for 1 month, and then
every 1.5-3 months for 1 year.

PROJECTED ACCRUAL: Approximately 69 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV breast cancer
Disease progression following prior adjuvant chemotherapy (no disease progression during
treatment with prior doxorubicin) Bidimensionally measurable disease Prior radiotherapy
allowed if disease completely outside radiation port or histologic evidence of measured
area indicating malignancy and not radiation fibrosis No CNS metastases Brain metastases
previously treated with radiotherapy or surgical excision allowed if no evidence of
residual metastases on brain CT or MRI Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Premenopausal or
postmenopausal Performance status: ECOG 0-1 Life expectancy: Greater than 16 weeks
Hematopoietic: WBC at least 2,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin
greater than 9 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 1.5 times
upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN Renal: Not
specified Cardiovascular: No symptomatic New York Heart Association class II or greater
congestive heart failure No significant arrhythmia requiring drug therapy No myocardial
infarction within the past 6 months No uncontrolled cardiac disease or unstable angina
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No other malignancy within the past 5 years except basal cell skin cancer or
carcinoma in situ of the cervix No preexisting clinically significant peripheral
neuropathy (no prior neuropathy of any grade if previously treated with paclitaxel) No
unstable, preexisting medical condition No serious active infection No other underlying
medical, psychological, familial, sociologic, or geographic condition that would preclude

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior hematopoietic
growth factors (filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa) At least 7
days since prior platelet transfusion Chemotherapy: See Disease Characteristics No prior
vinca alkaloids (including vinorelbine or docetaxel) No other concurrent antineoplastic
agents Endocrine therapy: No concurrent anticancer hormonal agents Radiotherapy: See
Disease Characteristics No concurrent palliative radiotherapy Surgery: See Disease
Characteristics Other: No other concurrent investigational drug or device

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David J. Perry, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington Hospital Center


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



Washington Cancer Institute Washington, District of Columbia  20010
Washington Hospital Center Washington, District of Columbia  20010