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Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Receiving Weekly Docetaxel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00215748
Recruitment Status : Terminated (slow accrual)
First Posted : September 22, 2005
Last Update Posted : November 16, 2007
Information provided by:
Geriatric Oncology Consortium

Brief Summary:
This study is to explore the feasibility of an alternative dose of dexamethasone pre-medication in older breast and lung cancer patients who are receiving weekly docetaxel chemotherapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Lung Cancer Drug: Dexamethasone Phase 2

Detailed Description:
Dose-limiting edema and effusions associated with cumulative docetaxel administraton have necessitated the recommendation that all patients should be premedicated with oral corticosteroids such as dexamethasone prior to docetaxel administration. Dexamethasone pre-medication may also decrease the incidence and severity of acute hypersensitivity reactions associated with docetaxel administration. However, administration of weekly dexamethasone can cause additional untoward side effects, especially in the older population. If the data from this phase II study is encouraging, a study to evaluate an even lower dose of dexamethasone can be conducted.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of A Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Treated With Weekly Docetaxel
Study Start Date : August 2004
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To evaluate the feasibility of a reduced dexamethasone pre-medication dose in elderly lung and breast cancer patients receiving weekly docetaxel therapy with respect to incidence of: Grade 3/4 fluid retention
  2. Grade 3/4 hypersensitivity

Secondary Outcome Measures :
  1. To evaluate the incidence of toxicity of a reduced dexamethasone pre-medication dose in elderly lung and breast cancer patients receiving weekly docetaxel with respect to: fluid retention (all grades)
  2. hypersensitivity (all grades)

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age ≥ 65 years;
  • breast or lung cancer patients to receive docetaxel therapy as per protocol;
  • corticosteroid administration, other than what is prescribed in this protocol, is not permitted during study participation, except topical administration and for adverse events;
  • performance status ECOG 0-2;
  • peripheral neuropathy ≤ 1;
  • adequate kidney and liver functions
  • signed study-specific informed consent

Exclusion Criteria:

  • Patients who have received an investigational drug within 4 weeks of registration;
  • Prior or concurrent malignancies (other than surgically treated carcinoma in situ;
  • Serious medical or psychiatric illness which would prevent informed consent;
  • Life expectancy < 3 months;
  • Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00215748

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United States, Maryland
Baltimore, Maryland, United States, 21211
Sponsors and Collaborators
Geriatric Oncology Consortium
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Principal Investigator: William Ershler, MD Geriatric Oncology Consortium

Layout table for additonal information Identifier: NCT00215748     History of Changes
Other Study ID Numbers: GOC S-010
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 16, 2007
Last Verified: November 2007

Keywords provided by Geriatric Oncology Consortium:

Additional relevant MeSH terms:
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Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators