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

Condition(s) targeted: Esophagitis; Pneumonitis; Non-Small Cell Lung Carcinoma

Intervention: Amifostine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: MedImmune LLC

Official(s) and/or principal investigator(s):
Luz Hammershaimb, M.D., Principal Investigator, Affiliation: MedImmune LLC

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.

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 design: Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Radiation Oncology Center, Sacramento, California 95816, United States

Cedars Sanai, Los Angeles, California 90048, United States

The Center for Cancer Care, Torrington, Connecticut 06790, United States

Florida Wellcare Alliance, Inverness, Florida 34452, United States

Sarasota Memorial Hospital, Sarasota, Florida 34239, United States

Ormand Memorial Cancer Center, Ormand Beach, Florida 32174, United States

Florida Community Cancer Center, New Port Richey, Florida 34652, United States

University Community Hospital-Center for Cancer Care, Tampa, Florida 33613, United States

University of Kentucky, Lexington, Kentucky 40536-0293, United States

Center for Cancer & Blood Disorders, Bethesda, Maryland 20817, United States

St. Agnes Health Care, Baltimore, Maryland 21229, United States

Chesapeake Oncology-Hematology Associates, Glen Burnie, Maryland 21061, United States

St. John's Medical Research, Springfield, Missouri 65807, United States

Cooper University Hospital, Camden, New Jersey 08103, United States

Upstate NY Cancer R&E Foundation, Rochester, New York 14623, United States

Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States

Beth Israel Hospital, New York, New York 10003, United States

New Hanover Radiation, Wilmington, North Carolina 28401, United States

Cancer Center of Upper Delaware Valley, Milford, Pennsylvania 18337, United States

Montgomery Cancer Center, Norristown, Pennsylvania 19401, United States

Charleston Cancer Center, Charleston, South Carolina 29406, United States

The Center for Radiation Oncology, Danville, Virginia 24541, United States

Valley Medical Center, Renton, Washington 98055, United States

Providence Everett Medical Center, Everett, Washington 98201, United States

Starting date: November 2003
Ending date: August 2006
Last updated: August 20, 2007