Clinical trial NCT00059943: Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer
Official title: Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lung Cancer
Prostate Cancer
Keywords: stage IV breast cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
recurrent breast cancer
stage IV prostate cancer
recurrent prostate cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-05-07
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Pharmacokinetics of docetaxel
Secondary outcomes:
measure: Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test
measure: Response
measure: Toxicity
measure: Correlation between toxicity and functional status decline
measure: Relationship between comorbid conditions at baseline and declines in functional status
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Arti Hurria, MD
role: STUDY_CHAIR
References: