Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: erlotinib hydrochloride; gemcitabine hydrochloride; therapeutic conventional surgery
Intervention description: oral administration; Intravenous administration
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; stage I pancreatic cancer; stage II pancreatic cancer

Summary:

      PURPOSE: This phase II trial is studying how well gemcitabine and erlotinib work when given
      before and after surgery in treating patients with pancreatic cancer that can be removed by
      surgery. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce
      the amount of normal tissue that needs to be removed. Giving these drugs after surgery may
      kill any tumor cells that remain after surgery.
    

Eligibility criteria:

        Eligibility Criteria:

          1. Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate
             process.

             NOTE: Patients with tumors of the pancreatic neck, body or tail are not eligible.
             Patients with evidence of neuroendocrine tumors, duodenal adenocarcinoma, or ampullary
             adenocarcinoma are not eligible.

          2. Localized, potentially resectable tumors as defined below. All patients must be staged
             with a chest X-ray or CT, and abdominal CT (contrast-enhanced, helical thin-cut) or
             MRI. Radiological resectability is defined by the following criteria on abdominal
             imaging:

               -  No evidence of tumor extension to the celiac axis, hepatic artery, or superior
                  mesenteric artery

               -  No evidence of tumor encasement or occlusion of the superior mesenteric vein
                  (SMV) or the SMV/portal vein confluence

               -  No evidence of visceral or peritoneal metastases

             NOTE: Patients with borderline resectable or marginally resectable pancreatic cancer
             are not eligible. Patients must meet all objective imaging criteria outlined above.

          3. ≥ 18 years of age

          4. ECOG/Zubrod performance status of 0 or 1

          5. Baseline weight loss ≤ 15% of premorbid weight

          6. Patient must have adequate hematologic, renal, and hepatic function as defined by:

               -  WBC ≥ 2,000 cells/mm³

               -  ANC ≥ 1,500 cells/mm³

               -  Platelets ≥ 100,000 cells/mm³

               -  Serum bilirubin ≤ 2.5 mg/dL

               -  Serum creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance of ≥ 50 ml/min
                  (24 hour urine collection)

               -  ALT < 2.5 times upper limit of normal (ULN)

               -  AST < 2.5 times ULN

               -  Albumin ≥ 3.2 g/dl

          7. No history of the following:

               -  Prior EGFR targeted therapy or therapy for pancreatic cancer

               -  Active infection requiring intravenous antibiotics at the time of registration

          8. Non-pregnant and non-breast feeding. Female participants of child bearing potential
             must have a negative urine or serum pregnancy test prior to registration.
             Perimenopausal participants must be amenorrheic ≥ 12 months to be considered not of
             childbearing potential. All patients of reproductive potential must agree to use an
             effective method of birth control while receiving study therapy.

          9. No prior malignancy within 5 years of registration (Exceptions: non-melanoma skin
             cancer, in-situ cancers)