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

Primary Purpose

Esophagitis, Pneumonitis, Non-Small Cell Lung Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amifostine
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophagitis focused on measuring - Non-Small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cedars Sanai
  • Radiation Oncology Center
  • The Center for Cancer Care
  • Florida Wellcare Alliance
  • Florida Community Cancer Center
  • Ormand Memorial Cancer Center
  • Sarasota Memorial Hospital
  • University Community Hospital-Center for Cancer Care
  • University of Kentucky
  • St. Agnes Health Care
  • Center for Cancer & Blood Disorders
  • Chesapeake Oncology-Hematology Associates
  • St. John's Medical Research
  • Cooper University Hospital
  • Long Island Jewish Medical Center
  • Beth Israel Hospital
  • Upstate NY Cancer R&E Foundation
  • New Hanover Radiation
  • Cancer Center of Upper Delaware Valley
  • Montgomery Cancer Center
  • Charleston Cancer Center
  • The Center for Radiation Oncology
  • Providence Everett Medical Center
  • Valley Medical Center

Outcomes

Primary Outcome Measures

- Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment.

Secondary Outcome Measures

- Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT.

Full Information

First Posted
April 7, 2004
Last Updated
August 20, 2007
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00081315
Brief Title
Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagitis, Pneumonitis, Non-Small Cell Lung Carcinoma
Keywords
- Non-Small cell lung cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
130 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amifostine
Primary Outcome Measure Information:
Title
- Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment.
Secondary Outcome Measure Information:
Title
- Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luz Hammershaimb, M.D.
Organizational Affiliation
MedImmune LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sanai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Radiation Oncology Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
The Center for Cancer Care
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Florida Wellcare Alliance
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Florida Community Cancer Center
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Ormand Memorial Cancer Center
City
Ormand Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
University Community Hospital-Center for Cancer Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States
Facility Name
St. Agnes Health Care
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Center for Cancer & Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Chesapeake Oncology-Hematology Associates
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
St. John's Medical Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Beth Israel Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Upstate NY Cancer R&E Foundation
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
New Hanover Radiation
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Cancer Center of Upper Delaware Valley
City
Milford
State/Province
Pennsylvania
ZIP/Postal Code
18337
Country
United States
Facility Name
Montgomery Cancer Center
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Charleston Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
The Center for Radiation Oncology
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Providence Everett Medical Center
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Valley Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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