Breast Cancer Clinical Trial
Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer
Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with metastatic breast, lung, or prostate cancer.
Full Description
OBJECTIVES:
Determine the pharmacokinetics of docetaxel in older patients with metastatic breast, lung, or prostate cancer.
Determine the response of patients treated with this drug.
Determine the toxicity of this drug in these patients.
Determine the short-term changes in functional status, in terms of activities of daily living, independent activities of daily living, and Karnofsky performance status, in patients treated with this drug.
Correlate the number of comorbid conditions at baseline with declines in functional status in patients treated with this drug.
OUTLINE: Patients receive docetaxel IV over 30 minutes once weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically proven metastatic breast, lung, or prostate cancer
Measurable disease
No untreated CNS metastases
No symptomatic CNS metastases requiring escalating doses of corticosteroids
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age
65 and over
Sex
Not specified
Menopausal status
Not specified
Performance status
Karnofsky 70-100%
Life expectancy
Not specified
Hematopoietic
Absolute neutrophil count at least 1,500/mm^3
Hemoglobin at least 8.0 g/dL
Platelet count at least 100,000/mm^3
Hepatic
Bilirubin normal
SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) with alkaline phosphatase no greater than ULN OR
Alkaline phosphatase no greater than 4 times ULN with SGOT and SGPT no greater than ULN
Renal
Not specified
Cardiovascular
No history of cardiac arrhythmia
No congestive heart failure
No myocardial infarction within the past 6 months
Other
No prior severe hypersensitivity reaction to docetaxel or other drugs containing polysorbate 80
No allergy to macrolide antibiotics
No grade 2 or greater peripheral neuropathy
No concurrent serious or uncontrolled infection
Able to read, write, and converse in English
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Recovered from prior chemotherapy
Endocrine therapy
See Disease Characteristics
Radiotherapy
Recovered from prior radiotherapy
Surgery
Not specified
Other
No concurrent CYP3A4-inducing or inhibiting medications or herbal remedies
No concurrent grapefruit juice
No concurrent ethanol
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There is 1 Location for this study
New York New York, 10021, United States
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