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

Memorial Sloan Kettering Cancer Center

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Breast Cancer Lung Cancer Prostate Cancer

Interventions

docetaxelDRUG

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Pharmacokinetics of docetaxel

Secondary Outcomes

Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test

Response

Toxicity

Correlation between toxicity and functional status decline

Relationship between comorbid conditions at baseline and declines in functional status

Data from ClinicalTrials.gov

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