Breast CancerPhase 2NCT00215748
Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Receiving Weekly Docetaxel
A Phase 2 study testing Dexamethasone in people with Breast Cancer and Lung Cancer, run by Geriatric Oncology Consortium at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer
- What is being tested?
- Dexamethasone
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Lung Cancer
- Being tested
- Dexamethasone
- Keywords
- Elderly, Weekly
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2004
- Study completionApr 2007
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geriatric Oncology Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- William Ershler, MD, Principal investigator, Geriatric Oncology Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215748
- Sponsor's protocol ID
- GOC S-010
- Status last verified
- Nov 2007
- First submitted
- 19 Sep 2005
- Last updated
- 16 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of A Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Treated With Weekly Docetaxel
- ClinicalTrials.gov ID
- NCT00215748
- Acronym / sponsor ID
- GOC S-010
- Conditions
- Breast Cancer, Lung Cancer
- Keywords
- Elderly, Weekly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Geriatric Oncology ConsortiumUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Aug 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone | Drug | – |
Primary outcome
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
2 secondary outcomes
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)
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2007.
- Geriatric Oncology Consortium websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Ershler, MD principal investigator
Geriatric Oncology Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone in people with Breast Cancer and Lung Cancer, run by Geriatric Oncology Consortium at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2007.