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

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Sanofi
Information provided by:
Geriatric Oncology Consortium
ClinicalTrials.gov Identifier:
NCT00215748
First received: September 19, 2005
Last updated: November 15, 2007
Last verified: November 2007

September 19, 2005
November 15, 2007
August 2004
Not Provided
  • 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
  • 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 hypersensitivity
  • • Grade 3/4 fluid retention
Complete list of historical versions of study NCT00215748 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
  • • hypersensitivity (all grades)
Not Provided
Not Provided
 
Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Receiving Weekly Docetaxel
Feasibility of A Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Treated With Weekly Docetaxel

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Lung Cancer
Drug: Dexamethasone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
April 2007
Not Provided

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215748
GOC S-010
Not Provided
Not Provided
Geriatric Oncology Consortium
Sanofi
Principal Investigator: William Ershler, MD Geriatric Oncology Consortium
Geriatric Oncology Consortium
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP