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

NCT ID: NCT01272791

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-03-31

Brief Summary

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.

Detailed Description

This is prospective, randomized, open-label, multicenter, phase 2 study of gemcitabine with or without bavituximab in patients with previously untreated stage IV pancreatic cancer.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine, bavituximab

Gemcitabine will be administered on Days 1, 8, 15 of each 28-day (4 weeks) cycle until disease progression or unacceptable toxicities. Patients randomized to receive bavituximab will receive 3 mg/kg weekly (in addition to gemcitabine) until disease progression or unacceptable toxicities

Group Type: EXPERIMENTAL

bavituximab

Intervention Type: BIOLOGICAL

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

Gemcitabine

Patients randomized to 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.

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: BIOLOGICAL

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

Intervention Type: DRUG

Other Intervention Names

Gemzar; Gemzar

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peregrine Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Sklenar

Role: STUDY_CHAIR

Peregrine Pharmaceuticals

Locations

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

Countries

United States; Ukraine

Other Identifiers

PPHM 1002

Identifier Type: -

Identifier Source: org_study_id