Spots Global Cancer Trial Database for Safety and Efficacy Study of Different Doses of 90Y-hPAM4 Combined With Gemcitabine in Pancreatic Cancer
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Trial Identification
Brief Title: Safety and Efficacy Study of Different Doses of 90Y-hPAM4 Combined With Gemcitabine in Pancreatic Cancer
Official Title: A Phase Ib/II Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Patients With Previously Untreated Advanced Pancreatic Cancer.
Study ID: NCT00603863
Conditions
Interventions
Study Description
Brief Summary: This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination with gemcitabine in patients with previously untreated pancreatic cancer.
Detailed Description: Patients receive a 4-week treatment cycle with once-weekly 30-minute gemcitabine infusions beginning one week prior to the first 90Y-hPAM4dose and continuing during the 3 consecutive weeks over which once weekly 90Y-hPAM4 doses are given. Depending on toxicity, patient cohorts will receive one of several possible 90Y and gemcitabine dose combinations. Post-treatment evaluations conducted until instituting another 90YhPAM4 treatment cycle, maintenance gemcitabine or for a maximum period of 12 weeks.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Christiana Care Health Services, Newark, Delaware, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Herbert Werthem College of Medicine/Jackson North Medical Center, Miami, Florida, United States
Moffit Cancer Center, Tampa, Florida, United States
Winship Cancer Institute/Emory University Hospital, Atlanta, Georgia, United States
Goshen Cancer Center, Goshen, Indiana, United States
New York Presbyterian Hospital/Weill Cornell Medical Center, New York, New York, United States
Mt. Sinai Medical Center, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Ohio State University Medical Center, Columbus, Ohio, United States
Thomas Jefferson University Medical Center, Philadelphia, Pennsylvania, United States
Contact Details
Name: William Wegener, MD, PHD
Affiliation: Gilead Sciences
Role: STUDY_CHAIR
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