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Brief Title: A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer
Official Title: A Phase 2 Randomized, Double-Blind, Multicenter Trial of Amplimexon® Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy Naïve Pancreatic Adenocarcinoma (Stage IV)
Study ID: NCT00637247
Brief Summary: The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Birmingham Hematology and Oncology- US Oncology, Birmingham, Alabama, United States
AZ Onc Associates D.B.A. Hematology Oncology- US Oncology, Tucson, Arizona, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
Rocky Mountain Cancer Center- US Oncology, Denver, Colorado, United States
Ocala Oncology Center- US Oncology, Ocala, Florida, United States
Cancer Centers of Florida- US Oncology, Orlando, Florida, United States
Peachtree Hematology and Oncology Consultants, Atlanta, Georgia, United States
Hematology Oncology Associates of Illinois- US Oncology, Chicago, Illinois, United States
Cancer Care & Hematolog Specialists of Chicagoland- US Oncology, Niles, Illinois, United States
Central Indiana Cancer Centers- US Oncology, Indianapolis, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Hope Center- US Oncology, Terre Haute, Indiana, United States
University of Kentucky, Hematology/Oncology/BMT Clinical Research, Lexington, Kentucky, United States
Lahey Clinic, Burlington, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Kansas City Cancer Center, LLC- US Oncology, Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada- US Oncology, Las Vegas, Nevada, United States
Hunterdon Regional Cancer Center, Flemington, New Jersey, United States
Hematology Oncology Associates, Mount Holly, New Jersey, United States
Hematology Oncology Associates, Albuquerque, New Mexico, United States
University of New Mexico, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center South, Las Cruces, New Mexico, United States
New Mexico Cancer Care Associates- US Oncology, Santa Fe, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Cancer Center of North Carolina- US Oncology, Raleigh, North Carolina, United States
Medical Onc Assoc of Wyoming Valley, PC- US Oncology, Kingston, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Pottstown Memorial Medical Center, Pottstown, Pennsylvania, United States
Associates in Hematology-Oncology P.C. US Oncology, Upland, Pennsylvania, United States
Reading Hospital Regional Medical Center, West Reading, Pennsylvania, United States
Sanford Clinic, Sioux Falls, South Dakota, United States
Texas Oncology - Amarillo- US Oncology, Amarillo, Texas, United States
Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology, Beaumont, Texas, United States
Texas Oncology P.A.- Bedford- US Oncology, Bedford, Texas, United States
Texas Cancer Center at Medical City- US Oncology, Dallas, Texas, United States
Texas Oncology P.A. - Dallas- US Oncology, Dallas, Texas, United States
Methodist Charlton Cancer Center - Texas Oncology- US Oncology, Dallas, Texas, United States
Texas Oncology - Odessa- US Oncology, Odessa, Texas, United States
Scott and White Hospital and Clinics, Temple, Texas, United States
Texas Oncology Cancer Care and Research Center- US Oncology, Waco, Texas, United States
Texoma Cancer Center- US Oncology, Wichita Falls, Texas, United States
Virginia Oncology Associates- US Oncology, Norfolk, Virginia, United States
Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US Oncology, Salem, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Cancer Care Northwest- US Oncology, Spokane, Washington, United States
Northwest Cancer Specialists- US Oncology, Vancouver, Washington, United States
Name: Evan Hersh, MD
Affiliation: AmpliMed Corporation
Role: STUDY_DIRECTOR
Name: Steven Cohen, MD
Affiliation: Fox Chase Cancer Center
Role: PRINCIPAL_INVESTIGATOR