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NCT00081315 Clinical Trial

Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer

Non-Small Cell Lung Carcinoma Clinical Trial

Official title:
Phase II, Randomized, Double-Blind, Multicenter Trial of Subcutaneous Amifostine (Ethyol®) Versus Placebo in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00081315
Other study ID # MI-CP079
Secondary ID
Status Completed
Phase Phase 2
First received April 7, 2004
Last updated August 20, 2007
Start date November 2003
Est. completion date August 2006

Study information
Verified date August 2007
Source MedImmune LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined modality therapy.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility You may be eligible for this study if you are 18 years of age or older and:

- Have UnResectable Stage IIIA or IIIB Non Small Cell Lung Cancer

- Have never had prior chemotherapy with Paclitaxel or Carboplatin

- Have never had prior thoracic radiation therapy (XRT)

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Amifostine

Locations
Country Name City State
United States St. Agnes Health Care Baltimore Maryland
United States Center for Cancer & Blood Disorders Bethesda Maryland
United States Cooper University Hospital Camden New Jersey
United States Charleston Cancer Center Charleston South Carolina
United States The Center for Radiation Oncology Danville Virginia
United States Providence Everett Medical Center Everett Washington
United States Chesapeake Oncology-Hematology Associates Glen Burnie Maryland
United States Florida Wellcare Alliance Inverness Florida
United States University of Kentucky Lexington Kentucky
United States Cedars Sanai Los Angeles California
United States Cancer Center of Upper Delaware Valley Milford Pennsylvania
United States Long Island Jewish Medical Center New Hyde Park New York
United States Florida Community Cancer Center New Port Richey Florida
United States Beth Israel Hospital New York New York
United States Montgomery Cancer Center Norristown Pennsylvania
United States Ormand Memorial Cancer Center Ormand Beach Florida
United States Valley Medical Center Renton Washington
United States Upstate NY Cancer R&E Foundation Rochester New York
United States Radiation Oncology Center Sacramento California
United States Sarasota Memorial Hospital Sarasota Florida
United States St. John's Medical Research Springfield Missouri
United States University Community Hospital-Center for Cancer Care Tampa Florida
United States The Center for Cancer Care Torrington Connecticut
United States New Hanover Radiation Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary - Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment.
Secondary - Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT.
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