Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia
Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
Phase
Type
Status
Age
Sponsor
Protocol IDs
Phase III, Phase II
Supportive care, Treatment
Active
18 and over
Other
001-0015-211
NCT00127387
Trial Description
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.
Further Study Information
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.
Eligibility Criteria
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
Trial Contact Information
Trial Lead Organizations/Sponsors
University of Texas Health Science Center at San Antonio
Sanchez Cancer Center
Charles R Thomas, Jr, MD Principal Investigator
Cecelia Simmons, RN, CCRC Ph: 210-616-5638
Email: simmonsc@uthscsa.edu
Charles R Thomas, Jr, MD Ph: 210-616-5684
Email: thomascr@uthscsa.edu
Trial Sites
U.S.A.
Texas
Votes:14
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