Expired Study
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New York, New York 10021


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.


Study summary:

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.


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


Study is Available At:


Original ID:

01-136


NCT ID:

NCT00059943


Secondary ID:

MSKCC-01136


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

65 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Arti Hurria, MD
Study Chair
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:September 2002
Primary Completion Date:September 2005
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 15, 2013
First Received Date:May 6, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:Pharmacokinetics of docetaxel
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Response
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Toxicity
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Correlation between toxicity and functional status decline
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Relationship between comorbid conditions at baseline and declines in functional status
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:docetaxel

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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