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

NCT00081315 | Completed Phase 2

• 1 other identifier: MI-CP079
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 24

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.

Conditions

Esophagitis; Pneumonitis; Non-Small Cell Lung Carcinoma

Keywords

- Non-Small cell lung cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Amifostine DRUG

Eligibility Criteria

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

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (24)

Cedars Sanai

Los Angeles, California, 90048, United States

Location

Radiation Oncology Center

Sacramento, California, 95816, United States

Location

The Center for Cancer Care

Torrington, Connecticut, 06790, United States

Location

Florida Wellcare Alliance

Inverness, Florida, 34452, United States

Location

Florida Community Cancer Center

New Port Richey, Florida, 34652, United States

Location

Ormand Memorial Cancer Center

Ormand Beach, Florida, 32174, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

University Community Hospital-Center for Cancer Care

Tampa, Florida, 33613, United States

Location

University of Kentucky

Lexington, Kentucky, 40536-0293, United States

Location

St. Agnes Health Care

Baltimore, Maryland, 21229, United States

Location

Center for Cancer & Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Chesapeake Oncology-Hematology Associates

Glen Burnie, Maryland, 21061, United States

Location

St. John's Medical Research

Springfield, Missouri, 65807, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Beth Israel Hospital

New York, New York, 10003, United States

Location

Upstate NY Cancer R&E Foundation

Rochester, New York, 14623, United States

Location

New Hanover Radiation

Wilmington, North Carolina, 28401, United States

Location

Cancer Center of Upper Delaware Valley

Milford, Pennsylvania, 18337, United States

Location

Montgomery Cancer Center

Norristown, Pennsylvania, 19401, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

The Center for Radiation Oncology

Danville, Virginia, 24541, United States

Location

Providence Everett Medical Center

Everett, Washington, 98201, United States

Location

Valley Medical Center

Renton, Washington, 98055, United States

Location

MeSH Terms

Conditions

Esophagitis; Pneumonia; Carcinoma, Non-Small-Cell Lung

Interventions

Amifostine

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• Luz Hammershaimb, M.D.

  MedImmune LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 9, 2004
• Study Start: November 1, 2003
• Study Completion: August 1, 2006
• Last Updated: August 21, 2007

Record last verified: 2007-08

Locations

US (24)