Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer

Completed · Phase 2

Conditions studied: Metastatic Pancreatic Cancer

In brief

The primary objective of this study is to compare the overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.

Key facts

Study ID

NCT01272791

Run by

Peregrine Pharmaceuticals

People needed

70

Starts

2011-01-01

Expected to finish

2013-03-01

Last updated by the study team

2017-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent has been obtained.
• Adults of 18 years of age or older with a life expectancy of at least 3 months.
• Patients with histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Adequate hematologic function (ANC ≥ 1,500 cells/µL; hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/µL).
• Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min).
• Adequate hepatic function (bilirubin ≤ 1.5 x ULN, ALT ≤ 3 x ULN, AST ≤ 3 x ULN); ALT and AST may be <5 x ULN if due to liver metastases.
• PT/INR ≤ 1.5 × ULN.
• aPTT ≤ 1.5 × ULN.
• Female patients must have a negative urine or serum pregnancy test at screening (pregnancy test not required for patients with bilateral oophorectomy and/or hysterectomy or for those patients who are > 1 year postmenopausal).
• All patients of reproductive potential must agree to use an approved form of contraception (as determined by the investigator).

You may not qualify if…

• Neuroendocrine tumors (carcinoid, islet cell cancer) of the pancreas.
• NYHA Class III or IV, cardiac function, myocardial infarction within 6 months prior to Day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease.
• Known brain, leptomeningeal or epidural metastases.
• Radiation therapy within 7 days of Study Day 1, lack of recovery from previous therapeutic radiation, or planned radiation therapy during the study period.
• Previously received any systemic treatment for pancreatic cancer, including prior neoadjuvant or adjuvant chemotherapy for lower stage disease.
• Previously malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years.
• Severe chronic obstructive or other pulmonary disease with hypoxemia.
• Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
• Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose anticoagulants to maintain patency of lines are eligible.
• Venous thromboembolic events (e.g. deep vein thrombosis or pulmonary embolism) within 6 months of screening.
• QTC interval of >470 ms on screening.
• Long QT syndrome or family history of sudden cardiac death in young family members.
• Subjects who participated in an investigational drug or device study within 28 days prior to study entry.
• Known active infection with HIV, hepatitis B, or hepatitis C.
• Females who are pregnant or breast-feeding.
• Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
• Unwillingness or inability to comply with the study protocol for any reason.

Where it is running

• Ironwood Cancer & Research Centers — Chandler, Arizona, United States
• Moores UCSD Cancer Center — La Jolla, California, United States
• Lynn Cancer Institute — Boca Raton, Florida, United States
• John B. Amos Cancer Center — Columbus, Georgia, United States
• The Cancer Center at DeKalb Medical — Decatur, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler — Savannah, Georgia, United States
• Joliet Oncology-Hematology Associates, Ltd. — Joliet, Illinois, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Arena Oncology Associates, PC — Lake Success, New York, United States
• Leo W. Jenkins Cancer Center - East Carolina University — Greenville, North Carolina, United States
• St. Luke's Cancer Center — Bethlehem, Pennsylvania, United States
• Vasicek Cancer Center at Scott & White Memorial Hospital — Temple, Texas, United States
• Lynchburg Hematology-Oncology Clinic — Lynchburg, Virginia, United States
• Municipal Institution "Cherkasy Regional Oncology Dispensary" of Cherkasy Regional Council — Cherkasy, Ukraine
• City Multi-field Clinical Hospital — Dnipropetrovsk, Ukraine
• Municipal Institution of Health Care "Kharkiv Regional Clinical Oncology Center" — Kharkiv, Ukraine
• Kyiv City Oncology Center — Kyiv, Ukraine

Full record on ClinicalTrials.gov

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