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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility of A Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Treated With Weekly Docetaxel

Conditions
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Breast Cancer, Lung Cancer

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dexamethasone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 
| Grade 3/4 hypersensitivity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 
| hypersensitivity (all grades) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Weekly