Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00059943|
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : January 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Lung Cancer Prostate Cancer||Drug: docetaxel||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||September 2005|
- Pharmacokinetics of docetaxel
- Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test
- Correlation between toxicity and functional status decline
- Relationship between comorbid conditions at baseline and declines in functional status
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|