COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00059943
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : January 16, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Lung Cancer Prostate Cancer Drug: docetaxel Phase 2

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

Primary Outcome Measures :
  1. Pharmacokinetics of docetaxel

Secondary Outcome Measures :
  1. Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test
  2. Response
  3. Toxicity
  4. Correlation between toxicity and functional status decline
  5. Relationship between comorbid conditions at baseline and declines in functional status

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00059943

Layout table for location information
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Arti Hurria, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00059943    
Other Study ID Numbers: 01-136
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action