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

Phase 2

Terminated

• Conditions: Breast Cancer; Lung Cancer

• Registration Number: NCT00215748
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-22
• Study Completion: 2007-04
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-15
• Last Update Posted: 2007-11-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
hypersensitivity (all grades)
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)