Status:
TERMINATED
Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Receiving Weekly Docetaxel
Lead Sponsor:
Geriatric Oncology Consortium
Collaborating Sponsors:
Sanofi
Conditions:
Breast Cancer
Lung Cancer
Eligibility:
All Genders
65+ years
Phase:
PHASE2
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 dex...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00215748
Start Date
August 1 2004
End Date
April 1 2007
Last Update
November 16 2007
Active Locations (1)
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1
Baltimore, Maryland, United States, 21211