Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Receiving Weekly Docetaxel
This study has been terminated.
(slow accrual)
Sponsor:
Geriatric Oncology Consortium
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
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Docetaxel
U.S. FDA Resources
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 |
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 May 21, 2013