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.
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
Breast CancerLung Cancer
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.
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
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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
65 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.