A Trial of Chemo & Radiation Therapy for Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine/Fluorouracil with External Beam Radiation
Intervention description: This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
Intervention MeSH terms: Gemcitabine; Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: pancreatic cancer, gemcitabine, 5-FU, cetuximab, radiation

Summary:

      This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and
      external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of pancreatic adenocarcinoma is required.

          -  Only patients with unresectable, non-metastatic tumors are eligible.

          -  Documentation of disease extent by endoscopic ultrasound and either laparotomy or
             laparoscopy must be performed within 42 days of registration.

          -  All patients will also be assessed by chest x-ray and abdominal-pelvic CT scan.

          -  Confirmation of palliative surgical bypass at the time of laparotomy or whether a
             biliary stent was placed will be requested.

          -  Disease must be locoregional and not amenable to surgery based on one or more of the
             following criteria:

               -  size of pancreatic tumor > 5 cm.

               -  lymph nodes (bulky, > 2 cm, but within a radiation port)

               -  vascular involvement or impingement of major vessels (superior mesenteric artery,
                  superior mesenteric vein, portal vein, hepatic artery).

               -  invasion into the adjacent structures.

          -  Patients with either measurable or evaluable disease are eligible.

          -  Patients with evidence of peritoneal seeding by malignancy are not eligible for the
             study.

          -  Patients with other evidence of metastatic disease are not eligible.

          -  Patients with concurrent malignancy of any site, except limited basal cell carcinoma
             or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, are
             ineligible.

          -  Patients with any other malignancy within 5 years of study entry, except curatively
             treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in
             situ of the cervix, are ineligible.

          -  Patients may not have had prior therapy for carcinoma of the pancreas, nor prior
             abdominal radiation therapy.

          -  Age > 18 years.

          -  CTC performance status < 2.

          -  No myocardial infarction in the past six months.

          -  No major surgery in the past two weeks.

          -  No uncontrolled serious medical or psychiatric illness.

          -  Required Initial Laboratory Data:

               -  Total bilirubin < 2.0 mg/dl

               -  AST < 3x upper limits of normal.

               -  Serum creatinine < 2.0 mg/dl

               -  WBC > 3,000/mm3 (ANC>1500/mm3)

               -  Platelets > 100,000 mm3

               -  CA 19-9

          -  Required Diagnostic procedures:

               -  Chest X-ray

               -  Abdominal pelvic CT scan

               -  EUS

               -  Staging laparoscopy or staging laparotomy

        Exclusion Criteria:

        Enrollment in this trial will be limited to patients for whom protocol therapy is safe and
        appropriate. Physicians should consider the risks and benefits of therapy together with all
        relevant medical and other considerations in deciding whether this protocol is appropriate
        for a particular patient. Specific considerations include:

          -  Psychiatric illness which would prevent the patient from giving informed consent.

          -  Serious medical illness such as uncontrolled infection, severe cardiovascular disease
             including recent (< 6 months) myocardial infarction or uncontrolled congestive heart
             failure, or other serious illness which would limit anticipated survival to < 12
             weeks.

          -  Protocol treatment would pose significant risk to an unborn child. Pregnant women
             should not be enrolled, and women of child-bearing age should be strongly encouraged
             to practice effective birth control during and for three months after the trial.

          -  Inability to swallow medication. Patients should have adequate, unassisted oral
             intake.