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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2007-04-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Lung Cancer

Keywords

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Elderly Weekly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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William Ershler, MD

Role: PRINCIPAL_INVESTIGATOR

Geriatric Oncology Consortium

Locations

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Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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GOC S-010

Identifier Type: -

Identifier Source: org_study_id