Breast Cancer, Lung Cancer, Prostate Cancer
Conditions
Keywords
stage IV breast cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer
Brief 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.
Detailed 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.
Interventions
DRUGdocetaxel
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of docetaxel | — |
Secondary
| Measure | Time frame |
|---|---|
| Response | — |
| Toxicity | — |
| Correlation between toxicity and functional status decline | — |
| Relationship between comorbid conditions at baseline and declines in functional status | — |
| Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test | — |
Countries
United States
Outcome results
None listed