Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00059943

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.

Condition	Intervention	Phase
Breast Cancer Lung Cancer Prostate Cancer	Drug: docetaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Lung Cancer Prostate Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Pharmacokinetics of docetaxel [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test [ Designated as safety issue: No ]
Response [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Correlation between toxicity and functional status decline [ Designated as safety issue: Yes ]
Relationship between comorbid conditions at baseline and declines in functional status [ Designated as safety issue: No ]

Study Start Date:

September 2002

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

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059943

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Arti Hurria, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000298989, MSKCC-01136
Study First Received:	May 6, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00059943 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Prostatic Diseases
Skin Diseases
Genital Neoplasms, Male
Antineoplastic Agents
Breast Neoplasms
Urogenital Neoplasms
Genital Diseases, Male
Pharmacologic Actions

Docetaxel
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Prostatic Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010