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

Phase 2
65 Years
Not Enrolling
Breast Cancer, Lung Cancer

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

William Ershler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Geriatric Oncology Consortium


United States: Institutional Review Board

Study ID:

GOC S-010



Start Date:

August 2004

Completion Date:

April 2007

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Elderly
  • Weekly
  • Breast Neoplasms
  • Lung Neoplasms



Baltimore, Maryland  21287