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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00127387
Other study ID # 001-0015-211
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received August 3, 2005
Last updated June 22, 2012
Start date May 2001
Est. completion date November 2005

Study information

Verified date June 2012
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 54
Est. completion date November 2005
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Poor PS

- Planned radiation therapy for less than 4 weeks or 4000Gy

- Limited disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic


Intervention

Drug:
Enbrel


Locations

Country Name City State
United States University of Texas Health Science Center at San Antonio San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio Sanchez Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo
Secondary Safety profile for enbrel taken by this group of individuals
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