Breast Cancer Clinical Trial
Vinorelbine in Treating Older Women With Stage IV Breast Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer.
Full Description
OBJECTIVES:
Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine.
Determine the toxicity profile of this drug in these patients.
Determine the time to progression in patients treated with this drug.
Determine the quality of life of patients treated with this drug.
Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients.
OUTLINE: Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then after completion of the second course.
Patients are followed every 3 months for 5 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage IV breast cancer
Eligible to receive first- or second-line chemotherapy
At least 1 unidimensionally measurable lesion
At least 20 mm in longest diameter
Must be completely outside prior irradiation port unless there is proof of progressive disease after completion of prior radiotherapy
No untreated brain metastases
Current metastatic CNS disease allowed only if previously treated and clinically stable at study entry
No meningeal carcinomatosis
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age:
65 and over
Sex:
Female
Menopausal status:
Not specified
Performance status:
ECOG 0-2
Life expectancy:
At least 12 weeks
Hematopoietic:
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
Direct bilirubin normal if total bilirubin elevated or less than 2.5 times ULN because of Gilbert's syndrome
Renal:
Creatinine no greater than 2 times ULN
Other:
No grade 2 or greater peripheral neuropathy
No other significant medical condition that would preclude study
No active infection within the past 2 weeks
No dysphagia or inability to swallow intact capsules
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
See Disease Characteristics
No more than 1 prior chemotherapy regimen for metastatic disease
No prior vinca alkaloids
At least 4 weeks since other prior chemotherapy and recovered
Endocrine therapy:
Prior hormonal therapy allowed
No concurrent hormonal therapy
Radiotherapy:
See Disease Characteristics
No prior radiotherapy to 25% or more of bone marrow
At least 3 weeks since prior radiotherapy and recovered
Surgery:
At least 3 weeks since prior major surgery
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There are 18 Locations for this study
Scottsdale Arizona, 85259, United States
Peoria Illinois, 61602, United States
Urbana Illinois, 61801, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50309, United States
Sioux City Iowa, 51101, United States
Wichita Kansas, 67214, United States
Ann Arbor Michigan, 48106, United States
Duluth Minnesota, 55805, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Saint Louis Park Minnesota, 55416, United States
Omaha Nebraska, 68106, United States
Bismarck North Dakota, 58501, United States
Grand Forks North Dakota, 58201, United States
Danville Pennsylvania, 17822, United States
Rapid City South Dakota, 57709, United States
Sioux Falls South Dakota, 57104, United States
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