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Completed

NCT Number: NCT00059943

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

Primary outcomes

  1. Pharmacokinetics of docetaxel

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer

Important dates

Study start
2002
Primary completion
2005
First posted
May 7, 2003
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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