Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer

Conditions
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Breast Cancer, Lung Cancer, Prostate Cancer

Intervention / Treatment
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* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of docetaxel |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test |  |  | 
| Response |  |  | 
| Toxicity |  |  | 
| Correlation between toxicity and functional status decline |  |  | 
| Relationship between comorbid conditions at baseline and declines in functional status |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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