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

NCT01272791 | Completed Phase 2

• 1 other identifier: PPHM 1002
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 19

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.

Conditions

Metastatic Pancreatic Cancer

Keywords

metastatic stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

  One year

• Duration of response (DR)

  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

  One year

• Safety

  One year

Study Arms (2)

Gemcitabine, bavituximab

EXPERIMENTAL

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

Gemcitabine

ACTIVE COMPARATOR

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

Interventions

bavituximab BIOLOGICAL

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

Also known as: Gemzar

Gemcitabine, bavituximab

Gemcitabine DRUG

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

Also known as: Gemzar

Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peregrine Pharmaceuticals: lead

Study Sites (19)

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

Location

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

The Cancer Center at DeKalb Medical

Decatur, Georgia, 30033, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Joliet Oncology-Hematology Associates, Ltd.

Joliet, Illinois, 60435, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Arena Oncology Associates, PC

Lake Success, New York, 11042, United States

Location

Leo W. Jenkins Cancer Center - East Carolina University

Greenville, North Carolina, 27834, United States

Location

St. Luke's Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Vasicek Cancer Center at Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Lynchburg Hematology-Oncology Clinic

Lynchburg, Virginia, 24501, United States

Location

Municipal Institution "Cherkasy Regional Oncology Dispensary" of Cherkasy Regional Council

Cherkasy, 18009, Ukraine

Location

City Multi-field Clinical Hospital

Dnipropetrovsk, 49102, Ukraine

Location

Municipal Institution of Health Care "Kharkiv Regional Clinical Oncology Center"

Kharkiv, 61070, Ukraine

Location

Kyiv City Oncology Center

Kyiv, 03115, Ukraine

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

bavituximab; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Thomas Sklenar

  Peregrine Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 10, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

UA (4); US (15)