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.
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
- Subjects with unresectable pancreatic cancer who have had surgery (exploratory
laparotomy, bilary, gastrointestinal bypass) are eligible, if the subject 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 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 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-EGFr antibody or 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
- Subjects 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). Subjects receiving coumadin
should have their 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
- Subject unwilling or unable to comply with study requirements
- Subject 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
