Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Arti Hurria

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00059943
Information obtained from ClinicalTrials.gov on February 06, 2012

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