Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00059943


Primary Contact:

Study Chair
Arti Hurria, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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