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

Primary Purpose

Breast Cancer, Lung Cancer, Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Pharmacokinetics of docetaxel

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2003
Last Updated
January 15, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00059943
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lung Cancer, Prostate Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Primary Outcome Measure Information:
Title
Pharmacokinetics of docetaxel
Secondary Outcome Measure Information:
Title
Correlation between docetaxel clearance with estimated cytochrome p450 activity by the Erythromycin Breath Test
Title
Response
Title
Toxicity
Title
Correlation between toxicity and functional status decline
Title
Relationship between comorbid conditions at baseline and declines in functional status

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arti Hurria, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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