NCT00059943CompletedPhase 2
Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Locations
- 2
- Primary Endpoint
- Pharmacokinetics of docetaxel
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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:
- •65 and over
- •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
- •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
- •Not specified
- •Cardiovascular
- •No history of cardiac arrhythmia
- •No congestive heart failure
- •No myocardial infarction within the past 6 months
- •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
- •Not specified
- •No concurrent CYP3A4-inducing or inhibiting medications or herbal remedies
- •No concurrent grapefruit juice
- •No concurrent ethanol
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pharmacokinetics of docetaxel
Secondary Outcomes
- 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
Investigators
Study Sites (2)
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