Trial Of Gemcitabine With Or Without Bavituximab In Patients With Previously Untreated Stage IV Pancreatic Cancer

Study Overview

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

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.

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.

Metastatic Pancreatic Cancer

BIOLOGICAL: bavituximab
DRUG: Gemcitabine

PPHM 1002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-01-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-04-18
First Submitted that Met QC Criteria 2011-01-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-04-19
First Posted (ACTUAL) 2011-01-10	Results First Posted N/A	Last Verified 2017-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 progre	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
ACTIVE_COMPARATOR: 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.	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 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 progre

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

ACTIVE_COMPARATOR: 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.

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

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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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
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
Duration of response (DR)	To determine the duration of response (DR) in each treatment arm.	One year
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
Safety	To evaluate safety by treatment arm	One year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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).

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Thomas Sklenar, Peregrine Pharmaceuticals

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record