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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

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

U.S.A.
Texas
	San Antonio
	University of Texas Health Science Center at San Antonio
		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
		Charles R Thomas, Jr, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00127387
Information obtained from ClinicalTrials.gov on May 27, 2008