Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung
This is a Phase II clinical trial evaluating the benefit from therapy with EC145 in patients with progressive adenocarcinoma of the lung.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Protocol EC-FV-03: A Phase II Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung|
- Percentage of patients deriving clinical benefit. [ Time Frame: Clinical benefit is defined as the ability to receive 4 or more cycles (i.e. months) of therapy without progression of disease. ] [ Designated as safety issue: No ]
- Tumor responses to EC145 therapy. [ Time Frame: Duration of EC145 therapy will vary according to individual patient response. ] [ Designated as safety issue: No ]
- Progression-free survival, response duration, and overall survival time observed after EC145 therapy. [ Time Frame: 2 years after completing therapy with EC145 and the 30-day follow-up period. ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||November 2011|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Induction phase of treatment: Two 4-week cycles; if stable disease or better at (week 8) CT, patient may proceed into maintenance phase.
Maintenance phase of treatment: 4-week cycles with CT every 8 weeks. Patients continue on study until they experience disease progression, unacceptable toxicity, or attain protocol-defined maximum benefit.
Induction: EC145 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle.
Maintenance: EC145 2.5 mg intravenous injection, Monday, Wednesday, and Friday, weeks 1 and 3 of each 4 week cycle.
At the investigator's discretion, patients may receive EC145 via an ambulatory pump after the first week of therapy has been administered in the clinic setting.
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 with EC145.
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.
|United States, California|
|Central Hematology Oncology Medical Group, INC|
|Alhambra, California, United States, 91801|
|Comprehensive Blood and Cancer Center|
|Bakersfield, California, United States, 93309|
|UCLA Division of Hematology-Oncology|
|Los Angeles, California, United States, 90095|
|North Valley Hematology/Oncology Medical Group|
|Northridge, California, United States, 91325|
|Ventura County Hematology-Oncology|
|Oxnard, California, United States, 93030|
|Cancer Care Associates Medical Group, Inc.|
|Redondo Beach, California, United States, 90277|
|Central Coast Medical Oncology Corporation|
|Santa Maria, California, United States, 93454|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|Division of Hematology/Oncology Research|
|Chicago, Illinois, United States, 60612|
|United States, Indiana|
|Horizon Oncology Center|
|Lafayette, Indiana, United States, 47905|
|United States, Maryland|
|University of Maryland Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|Center for Blood and Cancer Disorders|
|Bethesda, Maryland, United States, 20817|
|United States, Michigan|
|Great Lakes Cancer Institute MSU|
|Lansing, Michigan, United States, 48910|
|Providence Cancer Institute|
|Southfield, Michigan, United States, 48075|
|United States, Missouri|
|Washington University Medical School|
|St. Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Blumenthal Cancer Center|
|Charlotte, North Carolina, United States, 28277|
|United States, Pennsylvania|
|Donald Guthrie Foundation for Education and Research Clinical Research|
|Sayre, Pennsylvania, United States, 18840|
|United States, Texas|
|Houston, Texas, United States, 77031|
|United States, West Virginia|
|West Virginia University Mary Babb Randolph Cancer Center|
|Morgantown, West Virginia, United States, 26506|
|Study Director:||Richard A Messmann, MD, MHS, MSc||Endocyte|
|Principal Investigator:||Martin J Edelman, MD||University of Maryland Greenebaum Cancer Center|