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


Phase 2
65 Years
N/A
Not Enrolling
Both
Breast Cancer, Lung Cancer, Prostate Cancer

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics of docetaxel

Safety Issue:

No

Principal Investigator

Arti Hurria, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

01-136

NCT ID:

NCT00059943

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Prostate Cancer
  • 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
  • Breast Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021