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

Last updated: January 15, 2013
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Completed

Phase

2

Condition

Urologic Cancer

Breast Cancer

Lung Disease

Treatment

N/A

Clinical Study ID

NCT00059943
01-136
MSKCC-01136
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Study Start date:
September 01, 2002
Estimated Completion Date:

Study 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.

Connect with a study center

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

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