Adenocarcinoma of the Pancreas Treated With Panitumumab and Gemcitabine Regimen to Investigate Overall Survival as Primary Endpoint
Condition: Cancer of Pancreas; Cancer of the Pancreas; Pancreas Cancer; Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Intervention: Gemcitabine; panitumumab
Intervention description: Intravenous administration; Intravenous administration
Intervention MeSH terms: Gemcitabine; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a phase II, multi-center, open-label, single-arm clinical trial to be conducted in
      the United States. In approximately 55 centers, approximately 75 eligible locally advanced
      unresectable or metastatic pancreatic cancer subjects will be enrolled to receive first-line
      therapy of gemcitabine and panitumumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women ≥ 18 and ≤ 75 years of age

          -  Histologically or cytologically confirmed pancreatic adenocarcinoma meeting one of the
             following criteria: Locally advanced unresectable disease, or metastatic disease

          -  Measurable or unmeasurable disease

          -  Patients with unresectable pancreatic cancer who have had surgery (exploratory
             laparotomy, bilary, gastrointestinal bypass) are eligible, if the patient has fully
             recovered from surgery and ≥ 28 days has passed since the operation. Patients with
             history of pancreatoduodenectomy are eligible provided that there is radiographically
             documented disease recurrence

          -  Karnofsky performance score ≥ 60 %

          -  Life expectancy of ≥ 12 weeks as documented by the investigator

          -  Hematologic function, as follows: Absolute neutrophils count (ANC) ≥ 1.5 x 10^9/L,
             platelet count ≥ 100 x 10^9/L, and hemoglobin ≥ 9.0 g/dL

          -  Renal function, as follows: Serum creatinine ≤ 1.5 mg/dL

          -  Hepatic function, as follows: Aspartate aminotransferase (AST) ≤ 3 x upper limit of
             normal (ULN) (if liver metastases ≤ 5 x ULN), alanine aminotransferase (ALT) ≤ 3 x ULN
             (if liver metastases ≤ 5 x ULN), and total bilirubin ≤ 2.0 mg/dL. Patients with
             history of biliary obstruction are eligible after intervention, once this criteria is
             met.

          -  Metabolic function, as follows: Magnesium ≥ lower limit of normal, and calcium ≥ lower
             limit of normal

          -  Competent to comprehend, sign, and date an International Ethics
             Committee/Institutional Review board (IEC/IRB)-approved informed consent form

        Exclusion Criteria:

          -  Islet cell or acinar cell carcinoma or cystadenocarcinoma

          -  History or known presence of central nervous system (CNS) mestatases

          -  History of another primary cancer, except: Curatively treated cervical carcinoma in
             situ, or curatively resected non-melanomatous skin cancer, or other primary solid
             tumor curatively treated with no known active disease present and no treatment
             administered for ≥ 3 years prior to enrollment

          -  Other concurrent anticancer chemotherapy

          -  Concomitant malignant disease

          -  Prior radiotherapy ≤ 14 days, or if subjects has not recovered from radiotherapy

          -  Uncontrolled seizure disorder or other serious neurological diseases

          -  Any co-morbid disease that would increase risk of toxicity

          -  Prior anti-Epidermal growth factor receptor (EGFr) antibody or Vascular endothelial
             growth factor (VEGF) therapy (eg, cetuximab, bevacizumab) or treatment with small
             molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)

          -  Adjuvant chemotherapy or chemoradiotherapy ≥ 24 weeks prior to enrollment

          -  Prior treatment with gemcitabine

          -  Patients requiring chronic use of immunosuppressive agents (eg, methotrexate,
             cyclosporine, corticosteroids)

          -  Regular use (as determined by the investigator) of nonsteroidal anti-inflammatory
             agents

          -  Known allergy to panitumumab or any components of panitumumab formulation or
             gemcitabine

          -  Recent infection requiring a course of systemic anti-infectives that was completed ≤
             14 days before enrollment (exception can be made at the judgment of the investigator
             for oral treatment of an uncomplicated urinary tract infection [UTI])

          -  Clinically significant cardiovascular disease (including myocardial infarction,
             unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
             arrhythmia) ≤ 1 year prior to enrollment

          -  History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis or
             evidence of interstitial lung disease) on screening chest x-ray or computed tomography
             (CT) scan

          -  Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤
             8 weeks prior to enrollment

          -  Pre-existing bleeding diathesis or coagulopathy with the exception of well-controlled
             chronic anticoagulation (eg, coumadin or heparin therapy). Patients receiving coumadin
             should have their International Normalized Ratio (INR) monitored closely

          -  History of any medical or psychiatric condition or addictive disorder, or laboratory
             abnormality that, in the opinion of the investigator, may increase the risks
             associated with study participation or study drug administration or may interfere with
             the conduct of the study or interpretation of study results

          -  Patient unwilling or unable to comply with study requirements

          -  Patient who is pregnant or breast feeding

          -  Man or woman of child bearing potential (women who are post menopausal < 52 weeks, not
             surgically sterilized, or not abstinent) who do not consent to use adequate
             contraceptive precautions (per institutional standard of care) during the course of
             the study and for 24 weeks for women and 4 weeks for men, after the last dose of
             gemcitabine or panitumumab, whichever dose is last

          -  Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus,
             chronic active hepatitis B infection

          -  Major surgery ≤ 28 days or minor surgery ≤ 14 days prior to enrollment

          -  Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of
             enrollment