Lung CancerPhase 2/3NCT00127387
Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia
A Phase 2/3 study testing Enbrel in people with Lung Cancer and Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Patients who receive radiation therapy often have fatigue or a decrease in feeling well causing a "wasting" away. For patients with advanced disease of lung cancer, prostate cancer, or cancer that has spread to the bone, it is hoped that this drug may decrease this. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Prostate Cancer, Neoplasm Metastasis
- What is being tested?
- Enbrel
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to Nov 2005
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced lung, prostate, or bony metastasis for cancer
- Performance status (PS) of 3 or less
- Good lab test results with albumin of at least 2.5
- Radiation therapy of at least 4000Gy in 4 weeks
Who cannot join
- Poor PS
- Planned radiation therapy for less than 4 weeks or 4000Gy
- Limited disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Prospective, Randomized Pilot Study of Enbrel VS Placebo in Patients Receiving Radiation Therapy to Combat Fatigue and Cachexia
Patients who receive radiation therapy often have fatigue or a decrease in feeling well causing a "wasting" away. For patients with advanced disease of lung cancer, prostate cancer, or cancer that has spread to the bone, it is hoped that this drug may decrease this. If patients feel better during treatments they can complete the therapy without any breaks in treatment. For treatment to be most effective, it should be given in the amount needed, on a particular schedule.
Read the detailed description
Subjects will be placed in a group to receive either the drug enbrel, or a placebo. The radiation therapy treatments are as they would be given if the person was not on a research study. The selection of the group a patient is in is done by random, like flipping a coin. The doctor is not able to influence which group anyone is selected for. As is done routinely, radiation therapy is given Monday through Friday for about 4 to 6 weeks.The injections of enbrel or placebo are given two times a week. The enbrel or placebo is given as an injection directly under the skin with a small needle.
- Conditions
- Lung Cancer, Prostate Cancer, Neoplasm Metastasis, Bone Cancer
- Being tested
- Enbrel
- Keywords
- Bone metastasis, Radiation therapy, Lung cancer, Prostate cancer, Advanced lung cancer receiving radiation therapy, Advanced prostate cancer receiving radiation therapy, Any cancer with bone mets receiving radiation therapy
- Medical subject headings
- Lung Neoplasms, Prostatic Neoplasms, Neoplasm Metastasis, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnbrelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo
Secondary outcomes (1)
Safety profile for enbrel taken by this group of individuals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startMay 2001
- Primary completionSep 2005
- Study completionNov 2005
Why it stopped: PI moved to Oregon
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sanchez Cancer Center
- Investigators
- Charles R Thomas, Jr, MD, Principal investigator, U Texas Health Science Center San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127387
- Sponsor's protocol ID
- 001-0015-211
- Status last verified
- Jun 2012
- First submitted
- 3 Aug 2005
- Last updated
- 26 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Pilot Study of Enbrel VS Placebo in Patients Receiving Radiation Therapy to Combat Fatigue and Cachexia
- ClinicalTrials.gov ID
- NCT00127387
- Acronym / sponsor ID
- 001-0015-211
- Conditions
- Lung Cancer, Prostate Cancer, Neoplasm Metastasis, Bone Cancer
- Keywords
- Bone metastasis, Radiation therapy, Lung cancer, Prostate cancer, Advanced lung cancer receiving radiation therapy, Advanced prostate cancer receiving radiation therapy, Any cancer with bone mets receiving radiation therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI moved to Oregon
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Sanchez Cancer Center
- Study start
- May 2001
- Primary completion
- Sep 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 5 Aug 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.
Patients who receive radiation therapy often have fatigue or a decrease in feeling well causing a "wasting" away. For patients with advanced disease of lung cancer, prostate cancer, or cancer that has spread to the bone, it is hoped that this drug may decrease this. If patients feel better during treatments they can complete the therapy without any breaks in treatment. For treatment to be most effective, it should be given in the amount needed, on a particular schedule.
Detailed description
Subjects will be placed in a group to receive either the drug enbrel, or a placebo. The radiation therapy treatments are as they would be given if the person was not on a research study. The selection of the group a patient is in is done by random, like flipping a coin. The doctor is not able to influence which group anyone is selected for. As is done routinely, radiation therapy is given Monday through Friday for about 4 to 6 weeks.The injections of enbrel or placebo are given two times a week. The enbrel or placebo is given as an injection directly under the skin with a small needle.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced lung, prostate, or bony metastasis for cancer
- Performance status (PS) of 3 or less
- Good lab test results with albumin of at least 2.5
- Radiation therapy of at least 4000Gy in 4 weeks
Key exclusion criteria (3 listed)
- Poor PS
- Planned radiation therapy for less than 4 weeks or 4000Gy
- Limited disease
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 |
|---|---|---|
| Enbrel | Drug | – |
Primary outcome
Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo
1 secondary outcome
Safety profile for enbrel taken by this group of individuals
Results and safety
The study was stopped early (reason given: PI moved to Oregon). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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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.
Charles R Thomas, Jr, MD principal investigator
U Texas Health Science Center San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Enbrel in people with Lung Cancer and Prostate Cancer, run by The University of Texas Health Science Center at San Antonio 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 4 inclusion and 3 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 26 Jun 2012. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: PI moved to Oregon). 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?
Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo. 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 26 Jun 2012.