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

Metastatic Pancreatic Cancer Clinical Trial

Official title:

A Randomized, Open-Label, Phase 2 Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272791
• Other study ID #: PPHM 1002
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2011
• Last updated: April 18, 2017
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2017
• Source: Peregrine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Ukraine	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
United States	St. Luke's Cancer Center	Bethlehem	Pennsylvania
United States	Lynn Cancer Institute	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Ironwood Cancer & Research Centers	Chandler	Arizona
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	Leo W. Jenkins Cancer Center - East Carolina University	Greenville	North Carolina
United States	Joliet Oncology-Hematology Associates, Ltd.	Joliet	Illinois
United States	Moores UCSD Cancer Center	La Jolla	California
United States	Arena Oncology Associates, PC	Lake Success	New York
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Lynchburg Hematology-Oncology Clinic	Lynchburg	Virginia
United States	Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler	Savannah	Georgia
United States	Vasicek Cancer Center at Scott & White Memorial Hospital	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Countries where clinical trial is conducted

United States,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.	To compare the overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.	One year
Secondary	Progression-free survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.	To compare the progression-free survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.	One year
Secondary	Determine overall response rate (ORR)	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.	One year
Secondary	Duration of response (DR)	To determine the duration of response (DR) in each treatment arm.	One year
Secondary	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	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	One year
Secondary	Safety	To evaluate safety by treatment arm	One year