Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00059943 |
Recruitment Status
:
Completed
First Posted
: May 7, 2003
Last Update Posted
: January 16, 2013
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Lung Cancer Prostate Cancer | Drug: docetaxel | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer |
Study Start Date : | September 2002 |
Actual Primary Completion Date : | September 2005 |

- Pharmacokinetics of docetaxel
- Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test
- Response
- Toxicity
- Correlation between toxicity and functional status decline
- Relationship between comorbid conditions at baseline and declines in functional status

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Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059943
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Arti Hurria, MD | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00059943 History of Changes |
Other Study ID Numbers: |
01-136 MSKCC-01136 |
First Posted: | May 7, 2003 Key Record Dates |
Last Update Posted: | January 16, 2013 |
Last Verified: | January 2013 |
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 |