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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Study Description
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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:

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.


Study Design
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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
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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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

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00059943


Locations
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)
Investigators
Study Chair: Arti Hurria, MD Memorial Sloan Kettering Cancer Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00059943     History of Changes
Other Study ID Numbers: 01-136
MSKCC-01136
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:
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action