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

This study has been completed.
Information provided by:
Memorial Sloan-Kettering Cancer Center Identifier:
First received: May 6, 2003
Last updated: January 15, 2013
Last verified: January 2013

May 6, 2003
January 15, 2013
September 2002
September 2005   (final data collection date for primary outcome measure)
Pharmacokinetics of docetaxel [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00059943 on Archive Site
  • 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 ]
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Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer
Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung 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.


  • 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.

Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Lung Cancer
  • Prostate Cancer
Drug: docetaxel
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2005   (final data collection date for primary outcome measure)


  • 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



  • 65 and over


  • Not specified

Menopausal status

  • Not specified

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • 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


  • 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


Biologic therapy

  • Not specified


  • Recovered from prior chemotherapy

Endocrine therapy

  • See Disease Characteristics


  • Recovered from prior radiotherapy


  • Not specified


  • No concurrent CYP3A4-inducing or inhibiting medications or herbal remedies
  • No concurrent grapefruit juice
  • No concurrent ethanol
65 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
01-136, MSKCC-01136
Not Provided
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Arti Hurria, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP