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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00059943
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 ClinicalTrials.gov 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 ]
Not Provided
Not Provided
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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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Lung Cancer
  • Prostate Cancer
Drug: docetaxel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
September 2005   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00059943
01-136, MSKCC-01136
Not Provided
Not Provided
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