NCT01272791 - Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

February 28, 2013

Study Completion Date

March 31, 2013

Conditions

Metastatic Pancreatic Cancer

Interventions

BIOLOGICAL

bavituximab

Patients who qualify for enrollment into the study will be randomized in a 1:1 ratio to receive study treatment of gemcitabine alone or gemcitabine with weekly 3 mg/kg bavituximab. Treatment for each patient will begin on Study Day 1. Gemcitabine (1000 mg/m2) will be given on Days 1, 8 and 15 of each 28 day cycle (4 weeks) until disease progression or unacceptable toxicities. Patients randomized to receive bavituximab will be treated weekly beginning on Day 1 of each cycle. Study visits are scheduled to occur every 7 (± 2) days for bavituximab administration (for patients randomized to receive bavituximab); gemcitabine administration will occur every 7 (± 2) days for the first 3 weeks of each 4-week cycle

DRUG

Gemcitabine

Gemcitabine (1000 mg/m2) will be given on Days 1, 8 and 15 of each 28 day cycle (4 weeks) until disease progression or unacceptable toxicities

Trial Locations (19)

11042

Arena Oncology Associates, PC, Lake Success

18009

"Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council", Cherkasy

18015

St. Luke's Cancer Center, Bethlehem

24501

Lynchburg Hematology-Oncology Clinic, Lynchburg

27834

Leo W. Jenkins Cancer Center - East Carolina University, Greenville

30033

The Cancer Center at DeKalb Medical, Decatur

30501

Northeast Georgia Medical Center, Gainesville

31405

Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler, Savannah

31904

John B. Amos Cancer Center, Columbus

33486

Lynn Cancer Institute, Boca Raton

49102

City Multi-field Clinical Hospital, Dnipropetrovsk

60435

Joliet Oncology-Hematology Associates, Ltd., Joliet

61070

"Municipal Institution of Health Care Kharkiv Regional Clinical Oncology Center", Kharkiv

76508

Vasicek Cancer Center at Scott & White Memorial Hospital, Temple

85224

Ironwood Cancer & Research Centers, Chandler

92093

Moores UCSD Cancer Center, La Jolla

02215

Beth Israel Deaconess Medical Center, Boston

03756

Dartmouth-Hitchcock Medical Center, Lebanon

03115

Kyiv City Oncology Center, Kyiv