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Phase II, Multi-center, Open-label, Single-Arm Study Using Gemcitabine and Panitumumab in the First-line Treatment of Subjects With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas

Phase 2
18 Years
75 Years
Not Enrolling
Cancer of Pancreas, Cancer of the Pancreas, Pancreas Cancer, Pancreatic Cancer

Thank you

Trial Information

Phase II, Multi-center, Open-label, Single-Arm Study Using Gemcitabine and Panitumumab in the First-line Treatment of Subjects With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas

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

- Known allergy to panitumumab or any components of panitumumab formulation or

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the overall survival (OS) in subjects with locally advanced unresectable or metastatic adenocarcinoma of the pancreas using gemcitabine and panitumumab as first-line treatment.

Outcome Time Frame:

Assessment at week 9 and Q4W thereafter

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

April 2009

Related Keywords:

  • Cancer of Pancreas
  • Cancer of the Pancreas
  • Pancreas Cancer
  • Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Research Site Boca Raton, Florida  
Research Site Ashland, Kentucky  
Research Site Baltimore, Maryland