Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine; Radiation Therapy; Erlotinib; Surgery
Intervention description: Arm A:
1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day.
Arm B:
400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day.; 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy.; 100 mg daily by mouth on days 1-42.; Surgical removal of the pancreas and duodenum
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adenocarcinoma of the pancreatic head; Pancreaticoduodenectomy; Preoperative chemotherapy; Chemoradiation; Resectable pancreatic cancer; Surgical removal of the pancreas and duodenum; External-beam radiation therapy; EBRT; Gemcitabine; Erlotinib

Summary:

      Primary Objective:

      To assess margin positive resection rate (R1 resection rate; defined as "tumor within 2 mm of
      surgical margin on final pathology report") in patients treated with preoperative
      chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy
      followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head.

      Secondary Objectives:

        -  To assess disease free survival

        -  To assess overall survival

        -  To assess patterns of local and distant failure
    

Eligibility criteria:

        Inclusion Criteria:

          1. Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate
             process is required prior to treatment. Islet cell tumors are not eligible.

          2. Patients must be staged with a physical exam, CXR, and contrast-enhanced CT. Only
             potentially resectable patients are eligible. Potentially resectable defined as: a) no
             extra pancreatic disease, b) no evidence (on CT) of tumor extension to the celiac axis
             or SMA, and c) no evidence (CT or angiogram) of occlusion of the SMV or SMPV
             confluence. Visceral angiography is optional. Laparoscopic staging is not part of the
             pretreatment evaluation for this study. Laparoscopy may be performed prior to planned
             laparotomy at surgeon's discretion. Staging needs to be done within 28 days of
             enrollment.

          3. Patients cannot have known hepatic or peritoneal metastases detected by ultrasound
             (US), CT scan, or laparotomy prior to treatment

          4. There will be no upper age restriction; patients with Karnofsky performance status
             greater than 70 are eligible.

          5. Adequate renal, and bone marrow function: • Leukocytes >= 3,000/uL • Absolute
             neutrophil count >= 1,500/uL • Platelets >= 100,000/Ul • Serum creatinine <= 2.0 mg/dL

          6. Hepatic function (endoscopic or percutaneous drainage as needed) • Total bilirubin < =
             2 X institutional upper limits of normal (ULN) • AST (SGOT)/ALT (SGPT) <= 5 X
             institutional ULN

          7. Patients must have no fever or evidence of infection or other coexisting medical
             condition that would preclude protocol therapy.

          8. Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this
             study; women of childbearing potential (defined as those who have not undergone a
             hysterectomy or who have not been postmenopausal for at least 24 consecutive months)
             must agree to practice adequate contraception and to refrain from breast feeding, as
             specified in the informed consent.

          9. Patients must sign a study-specific consent form, which is attached to this protocol.

        Exclusion Criteria:

          1. Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence)
             are not eligible.

          2. Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive
             heart failure

          3. Known presence of central nervous system or brain metastases

          4. Inability to comply with study and/or follow-up procedures

          5. Patients < 18 years of age.