NCT00215748

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 16, 2007

Status Verified

November 1, 2007

First QC Date

September 19, 2005

Last Update Submit

November 15, 2007

Conditions

Breast CancerLung Cancer

Keywords

ElderlyWeekly

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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)

Interventions

DexamethasoneDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Baltimore, Maryland, 21211, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsLung Neoplasms

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • William Ershler, MD

    Geriatric Oncology Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

August 1, 2004

Study Completion

April 1, 2007

Last Updated

November 16, 2007

Record last verified: 2007-11

Locations

US(1)