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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Pancreatic Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.

Outcome Description:

To compare the overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Thomas Sklenar

Investigator Role:

Study Chair

Investigator Affiliation:

Peregrine Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

PPHM 1002

NCT ID:

NCT01272791

Start Date:

January 2011

Completion Date:

March 2013

Related Keywords:

  • Metastatic Pancreatic Cancer
  • metastatic stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Northeast Georgia Medical CenterGainesville, Georgia  30501
John B. Amos Cancer CenterColumbus, Georgia  31904
Lynchburg Hematology-Oncology ClinicLynchburg, Virginia  24501
Joliet Oncology-Hematology Associates, Ltd.Flossmoor, Illinois  60422
Arena Oncology Associates, PCGreat Neck, New York  11021
St. Luke's Cancer CenterBethlehem, Pennsylvania  18015
Lynn Cancer InstituteBoca Raton, Florida  33428
Ironwood Cancer & Research CentersChandler, Arizona  85224
The Cancer Center at DeKalb MedicalDecatur, Georgia  30033
Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405
Leo W. Jenkins Cancer Center - East Carolina UniversityGreenville, North Carolina  27834
Vasicek Cancer Center at Scott & White Memorial HospitalTemple, Texas  76508