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

Phase 2

Completed

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Biological: bavituximab; Drug: Gemcitabine

• Registration Number: NCT01272791
• Lead Sponsor: Peregrine Pharmaceuticals

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Status Verified: 2017-04
• Disposition First Submitted: 2017-04-18
• Disposition First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Disposition First Posted: 2017-04-19
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine, bavituximab	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
Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.	One year	To compare the overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.

Secondary Outcome Measures

Name	Time	Method
Duration of response (DR)	One year	To determine the duration of response (DR) in each treatment arm.
Progression-free survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.	One year	To compare the progression-free survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.
Determine overall response rate (ORR)	One year	To determine the overall response rate \[complete response (CR) and partial response (PR)\] in stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.
Determine the frequency of 25% or greater reduction in CA 19-9 in patients with baseline CA 19-9>=2 time the upper limit of normal (ULN) at screening	One year	To determine the frequency of 25% or greater reduction in CA 19-9 in patients with baseline CA 19-9\>=2 time the upper limit of normal (ULN) at screening in each treatment arm
Safety	One year	To evaluate safety by treatment arm

Trial Locations

Locations (19)

Northeast Georgia Medical Center; 🇺🇸 Gainesville, Georgia, United States

Vasicek Cancer Center at Scott & White Memorial Hospital; 🇺🇸 Temple, Texas, United States

Municipal Institution "Cherkasy Regional Oncology Dispensary" of Cherkasy Regional Council; 🇺🇦 Cherkasy, Ukraine

St. Luke's Cancer Center; 🇺🇸 Bethlehem, Pennsylvania, United States

Joliet Oncology-Hematology Associates, Ltd.; 🇺🇸 Joliet, Illinois, United States

Arena Oncology Associates, PC; 🇺🇸 Lake Success, New York, United States

Lynn Cancer Institute; 🇺🇸 Boca Raton, Florida, United States

The Cancer Center at DeKalb Medical; 🇺🇸 Decatur, Georgia, United States

Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler; 🇺🇸 Savannah, Georgia, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Leo W. Jenkins Cancer Center - East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States

John B. Amos Cancer Center; 🇺🇸 Columbus, Georgia, United States

City Multi-field Clinical Hospital; 🇺🇦 Dnipropetrovsk, Ukraine

Lynchburg Hematology-Oncology Clinic; 🇺🇸 Lynchburg, Virginia, United States

Kyiv City Oncology Center; 🇺🇦 Kyiv, Ukraine

Municipal Institution of Health Care "Kharkiv Regional Clinical Oncology Center"; 🇺🇦 Kharkiv, Ukraine

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Ironwood Cancer & Research Centers; 🇺🇸 Chandler, Arizona, United States