Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer|
- Pharmacokinetics of docetaxel [ Designated as safety issue: No ]
- Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test [ Designated as safety issue: No ]
- Response [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Correlation between toxicity and functional status decline [ Designated as safety issue: Yes ]
- Relationship between comorbid conditions at baseline and declines in functional status [ Designated as safety issue: No ]
|Study Start Date:||September 2002|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059943
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Arti Hurria, MD||Memorial Sloan Kettering Cancer Center.|