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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00215748
• Other study ID #: GOC S-010
• Status: Terminated
• Phase: Phase 2
• First received: September 19, 2005
• Last updated: November 15, 2007
• Start date: August 2004
• Est. completion date: April 2007

Study information

• Verified date: November 2007
• Source: Geriatric Oncology Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer

Intervention

Drug:
• Dexamethasone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Geriatric Oncology Consortium	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Grade 3/4 hypersensitivity
Secondary	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)
Secondary	hypersensitivity (all grades)

External Links

•   Geriatric Oncology Consortium website