Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

NCT00127387 | Terminated Phase 2

• 1 other identifier: 001-0015-211
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Enbrel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Poor PS
• Planned radiation therapy for less than 4 weeks or 4000Gy
• Limited disease

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Sanchez Cancer Center: collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Prostatic Neoplasms; Neoplasm Metastasis; Bone Neoplasms

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Charles R Thomas, Jr, MD

  U Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2005
• First Posted: August 5, 2005
• Study Start: May 1, 2001
• Primary Completion: September 1, 2005
• Study Completion: November 1, 2005
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

US (1)