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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01272791
First received: January 3, 2011
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Pancreatic Cancer
Biological: bavituximab
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 2 Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
  • Overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab. [ Time Frame: One year ] [ Designated as safety issue: No ]
    To compare the overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.


Secondary Outcome Measures:
  • Progression-free survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab. [ Time Frame: One year ] [ Designated as safety issue: No ]
    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) [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.

  • Duration of response (DR) [ Time Frame: One year ] [ Designated as safety issue: No ]
    To determine the duration of response (DR) in each treatment arm.

  • 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 [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    To evaluate safety by treatment arm


Enrollment: 70
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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/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
Other Names:
  • Gemzar
  • bavituximab
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.
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
Other Name: Gemzar

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272791

Locations
United States, Arizona
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
United States, California
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
United States, Florida
Lynn Cancer Institute
Boca Raton, Florida, United States, 33486
United States, Georgia
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
The Cancer Center at DeKalb Medical
Decatur, Georgia, United States, 30033
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Illinois
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Arena Oncology Associates, PC
Lake Success, New York, United States, 11042
United States, North Carolina
Leo W. Jenkins Cancer Center - East Carolina University
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
St. Luke's Cancer Center
Bethlehem, Pennsylvania, United States, 18015
United States, Texas
Vasicek Cancer Center at Scott & White Memorial Hospital
Temple, Texas, United States, 76508
United States, Virginia
Lynchburg Hematology-Oncology Clinic
Lynchburg, Virginia, United States, 24501
Ukraine
Municipal Institution "Cherkasy Regional Oncology Dispensary" of Cherkasy Regional Council
Cherkasy, Ukraine, 18009
City Multi-field Clinical Hospital
Dnipropetrovsk, Ukraine, 49102
Municipal Institution of Health Care "Kharkiv Regional Clinical Oncology Center"
Kharkiv, Ukraine, 61070
Kyiv City Oncology Center
Kyiv, Ukraine, 03115
Sponsors and Collaborators
Peregrine Pharmaceuticals
Investigators
Study Chair: Thomas Sklenar Peregrine Pharmaceuticals
  More Information

No publications provided

Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01272791     History of Changes
Other Study ID Numbers: PPHM 1002
Study First Received: January 3, 2011
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Peregrine Pharmaceuticals:
metastatic stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 20, 2014