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

Geriatric Oncology Consortium

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Lung Cancer

Treatments

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00215748

GOC S-010

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.