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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Lung Cancer
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of A Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Treated With Weekly Docetaxel

Resource links provided by NLM:


Further study details as provided by Geriatric Oncology Consortium:

Primary Outcome Measures:
  • 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:
  • 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)

Estimated Enrollment: 40
Study Start Date: August 2004
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215748

Locations
United States, Maryland
Baltimore, Maryland, United States, 21211
Sponsors and Collaborators
Geriatric Oncology Consortium
Sanofi
Investigators
Principal Investigator: William Ershler, MD Geriatric Oncology Consortium
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00215748     History of Changes
Other Study ID Numbers: GOC S-010
Study First Received: September 19, 2005
Last Updated: November 15, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Geriatric Oncology Consortium:
Elderly
Weekly

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Docetaxel
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014