Official Title: “Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer”

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 Type: Interventional

Study Design: Treatment, Open Label

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.

Intervention(s) in this Clinical Trial

• Drug: docetaxel

Primary Measures

• Pharmacokinetics of docetaxel
  • Safety Issue?: No

Secondary Measures

• Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test
  • Safety Issue?: No
• Response
  • Safety Issue?: No
• Toxicity
  • Safety Issue?: Yes
• Correlation between toxicity and functional status decline
  • Safety Issue?: Yes
• Relationship between comorbid conditions at baseline and declines in functional status
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00059943

Study ID Number: CDR0000298989

ClinicalTrials.gov Identifier: NCT00059943

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database