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

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 2


Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
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 lung cancer prostate cancer

MedlinePlus related topics: Cancer Lung Cancer Prostate Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Memorial Sloan Kettering Cancer Center:

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
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00059943 History of Changes
Other Study ID Numbers:	01-136 MSKCC-01136
Study First Received:	May 6, 2003
Last Updated:	January 15, 2013
Health Authority:	United States: Federal Government

Keywords provided by Memorial Sloan Kettering Cancer Center:


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:


Breast Neoplasms Lung Neoplasms Prostatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases	Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016