Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer
65 Years
N/A
Both
Breast Cancer, Lung Cancer, Prostate Cancer
Trial Information
Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pharmacokinetics of docetaxel
Safety Issue:
No
Principal Investigator
Arti Hurria, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
01-136
NCT ID:
NCT00059943
Start Date:
September 2002
Completion Date:
Related Keywords:
- Breast Cancer
- Lung Cancer
- Prostate Cancer
- 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
- Breast Neoplasms
- Lung Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
