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

January 15, 2013 updated by: Memorial Sloan Kettering Cancer Center

Pharmacokinetics of Weekly Docetaxel in Patients Age 65 and Older With Metastatic Breast or Lung Cancer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetics of docetaxel

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Arti Hurria, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

May 6, 2003

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-136
  • MSKCC-01136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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