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

Breast Cancer Clinical Trial

Official title:

Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059943
• Other study ID #: 01-136
• Secondary ID: MSKCC-01136
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2003
• Last updated: January 15, 2013
• Start date: September 2002

Study information

• Verified date: January 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Lung Neoplasms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• docetaxel

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of docetaxel			No
Secondary	Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test			No
Secondary	Response			No
Secondary	Toxicity			Yes
Secondary	Correlation between toxicity and functional status decline			Yes
Secondary	Relationship between comorbid conditions at baseline and declines in functional status			No