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

Phase 2

Completed

• Conditions: Breast Cancer; Lung Cancer; Prostate Cancer

• Registration Number: NCT00059943
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2003-05-06
• Study First Submitted QC: 2003-05-06
• Study First Posted: 2003-05-07
• Primary Completion: 2005-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of docetaxel

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States