Protocol EC-FV-03: A Phase II Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung
This is a Phase II clinical trial of EC145 administered to patients with progressive
adenocarcinoma of the lung.
EC145 is a drug that is specifically designed to enter cancer cells via the folate vitamin
receptor (FR). Experimental evidence shows that this target receptor is expressed on a
significant portion of non-small cell lung cancers. Early clinical evidence in a small
number of Phase I patients suggests that EC145 is generally well-tolerated, without many of
the side-effects observed in more-standard therapeutic agents. This evidence suggests that
EC145 may be useful as a chemotherapy against progressive adenocarcinomas of the lung. The
primary objective of this study is to collect data on clinical benefit produced by therapy
All patients will undergo imaging with the FR targeting investigational imaging agent EC20
(FolateScan) during the screening period to confirm eligibility for the treatment portion of
the clinical trial. Clinical evidence suggests that EC20 may be used to identify patients
with cancers that express the target receptor.
Information about the safety and tolerability of both EC145 and EC20 will be assessed.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients deriving clinical benefit.
Clinical benefit is defined as the ability to receive 4 or more cycles (i.e. months) of therapy without progression of disease.
Richard A Messmann, MD, MHS, MSc
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Comprehensive Blood and Cancer Center||Bakersfield, California 93309|
|Methodist Hospital||Houston, Texas 77030|
|Blumenthal Cancer Center||Charlotte, North Carolina 28203|
|North Valley Hematology/Oncology Medical Group||Northridge, California 91328|
|Cancer Care Associates Medical Group, Inc.||Torrance, California 90505|
|Providence Cancer Institute||Southfield, Michigan 48075|
|University of Maryland Greenebaum Cancer Center||Baltimore, Maryland 21201|
|Central Coast Medical Oncology Corporation||Santa Maria, California 93454|
|Horizon Oncology Center||Lafayette, Indiana 47905|
|Central Hematology Oncology Medical Group, Inc||Alhambra, California 91801|
|Ventura County Hematology-Oncology||Oxnard, California 93030|
|UCLA Division of Hematology-Oncology||Los Angeles, California 90095|
|Division of Hematology/Oncology Research||Chicago, Illinois 60612|
|Center for Blood and Cancer Disorders||Bethesda, Maryland 20817|
|Great Lakes Cancer Institute MSU||Lansing, Michigan 48910|
|Washington University Medical School||St. Louis, Missouri 63110|
|Donald Guthrie Foundation for Education and Research Clinical Research||Sayre, Pennsylvania 18840|
|West Virginia University Mary Babb Randolph Cancer Center||Morgantown, West Virginia 26506|