Clinical trial NCT01272791: Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer
Official title: A Randomized, Open-Label, Phase 2 Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Keywords: metastatic stage IV pancreatic cancer
Lead sponsor: Peregrine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-01-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.
timeFrame: One year
Secondary outcomes:
measure: Progression-free survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.
timeFrame: One year
measure: Determine overall response rate (ORR)
timeFrame: One year
measure: Duration of response (DR)
timeFrame: One year
measure: 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
timeFrame: One year
measure: Safety
timeFrame: One year
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: Boca Raton
country: United States
facility: Lynn Cancer Institute
state: Florida
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Decatur
country: United States
facility: The Cancer Center at DeKalb Medical
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Savannah
country: United States
facility: Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler
state: Georgia
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd.
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Lake Success
country: United States
facility: Arena Oncology Associates, PC
state: New York
city: Greenville
country: United States
facility: Leo W. Jenkins Cancer Center - East Carolina University
state: North Carolina
city: Bethlehem
country: United States
facility: St. Luke's Cancer Center
state: Pennsylvania
city: Temple
country: United States
facility: Vasicek Cancer Center at Scott & White Memorial Hospital
state: Texas
city: Lynchburg
country: United States
facility: Lynchburg Hematology-Oncology Clinic
state: Virginia
city: Cherkasy
country: Ukraine
facility: Municipal Institution "Cherkasy Regional Oncology Dispensary" of Cherkasy Regional Council
city: Dnipropetrovsk
country: Ukraine
facility: City Multi-field Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Municipal Institution of Health Care "Kharkiv Regional Clinical Oncology Center"
city: Kyiv
country: Ukraine
facility: Kyiv City Oncology Center
Study officials:
affiliation: Peregrine Pharmaceuticals
name: Thomas Sklenar
role: STUDY_CHAIR
References: