7 Day's of Erlotinib Neo-adjuvant, Followed by Adjuvant Erlotinib-gemcitabine in Pancreatic Cancer Patients
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: erlotinib
Intervention description: Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib 100 mg daily 6 month/6 chemotherapy cycles. Gemcitabine 1000 m2 weekly after surgery for 6 cycles.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 19 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pancreatic; Cancer; Assay; Biomarkers

Summary:

      1.1 Primary Objective

      To evaluate the effects of short course preoperative erlotinib treatment in a panel of
      predictive biomarkers from a group of patients who undergo resection of pancreatic
      adenocarcinoma with curative intent.

      1.2 Secondary Objectives

      1.2.1 To analyze the effects of short course preoperative erlotinib treatment followed by
      postoperative erlotinib-gemcitabine therapy in the disease-free survival of patients who
      undergo curative intent resection of pancreatic adenocarcinoma.

      1.2.2 To evaluate secondary endpoints of disease response such as duration of overall
      survival and patterns of recurrence for patients with resectable pancreatic cancer who
      undergo this treatment regimen.

      1.2.3 To evaluate the plasma pharmacokinetics of erlotinib in pancreatic cancer patients both
      in the preoperative and postoperative setting, and to explore correlations between plasma and
      tumor erlotinib concentrations.

      1.2.4 To develop a clinically relevant predictive assay of response to erlotinib based on
      selected biomarkers in endoscopic ultrasound-fine needle aspiration (EUS-FNA) specimens when
      it can be obtained at the time of pancreatic cancer diagnosis in chemotherapy-naive patients.
    

Eligibility criteria:

        Inclusion Criteria:

        .Histologic or cytologic confirmation of pancreatic ductal adenocarcinoma.

          -  Pancreatic cancer must be surgically resectable: a) no evidence of distant metastasis;
             b) clear fat plane around the celiac and superior mesenteric arteries; c) patent
             portal and superior mesenteric veins

          -  No evidence of post-resection distant metastasis

          -  Pathologic confirmation of R0/R1 status following surgical resection

          -  Age ≥ 19 years

          -  Male or female gender (not pregnant or lactating). If the subject is fertile, use of
             medically acceptable contraception will be required.

          -  Patient should be able to understand and offer signed written informed consent prior
             to study entry.

          -  No prior receipt of chemotherapy or radiotherapy

          -  Patients must demonstrate a Eastern Cooperative Oncology Group(ECOG) P.S. of 0 or 1

          -  End Organ function must be adequate meeting the below criteria at baseline:

        White Blood Cell Count (WBC)> 3000/mm3, absolute neutrophil count(ANC)> 1500/mm3,
        Platelets>100,000mm3 Calculated creatinine clearance >50 ml/min, normal serum creatinine
        (mg/dL) (if calculated Crcl <50 ml/min, Crcl should measured and be > 50 ml/min) Bilirubin
        <3.0 mg/dL (patients with obstructive jaundice require preoperative endoscopic biliary
        stenting if total bilirubin >3.0 mg/dl) prothrombin time(PT) /partial thromboplastin
        time(PTT) below the upper limit of normal

        Exclusion Criteria:

          -  Diagnosis of active (treated in past 5 years) concomitant malignancy with exception of
             non-melanotic skin cancer

          -  Transplant patients or patients receiving immunosuppression

          -  Presence of an underlying disease state associated with active bleeding or a past
             medical history of coagulopathy

          -  New York Heart Association Class IV congestive heart failure

          -  Limited mental capacity or language skills to the extent simple instructions cannot be
             followed or information regarding adverse events cannot be provided

          -  History of non-compliance with prescribed medical care

        Post-Operative Phase Inclusion

          -  No Evidence of Post-Resection Distant Metastasis

          -  Pathological confirmation of R0/R1 status following Surgical resection

          -  Patient must demonstrate a post-operative performance status of 0 or 1.

          -  End Organ function must be adequate, meeting the below criteria at baseline:

               1. WBC > 3000/mm³,ANC > 1500/mm³, Platelets > 100,000 mm³

               2. Calculated Creatinine Clearance > 50 ml/min,Serum Creatinine < 1.5 mg/dl

               3. Bilirubin < 3.0 mg/dl; aspartate aminotransferase(AST) and alanine
                  aminotransferase (ALT) < 3 x normal value

               4. PT/PTT/international normalized ratio(INR) within normal Limits.

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