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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Lung Cancer

Prostate Cancer

Treatments

Drug: docetaxel

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00059943

01-136

MSKCC-01136

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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