A Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, . . .
A Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, . . .
In this study, a new chemotherapeutic agent, panitumumab, will be tested in combination with
 another chemotherapeutic drug, capecitabine, along with external radiotherapy, to find out
 whether this combination is effective and safe to use before surgery.
Surgical resection remains the standard procedure for patients with localized resectable
 pancreatic cancer.

 Neoadjuvant or preoperative therapy with chemotherapy and radiation therapy has been proposed
 as an alternative approach in patients with localized pancreatic adenocarcinoma.

 Advantages are: 1) early start of systemic therapy targeting micrometastatic disease; 2)
 increased compliance with chemoradiotherapy; 3) increase primary tumor complete resection
 rates; 4) avoidance of surgery in patients with rapidly developing metastatic disease; and 5)
 importantly, it provides an important resource for research in terms of tissue acquisition
 before and after therapy . Finally, this is an opportunity to test the safety and efficacy of
 a novel combination of weekly panitumumab, oral capecitabine and radiation in pancreatic
 cancer.
Inclusion Criteria:

 1. Cytological or histological confirmation of pancreatic adenocarcinoma is required.

 2. Only patients with localized and apparently resectable, non-metastatic tumors are
 eligible. All patients must be staged with a chest X-ray or chest CT and abdominal and
 pelvic CT scan or MRI.

 One of the following radiological criteria must be met and recorded in chart by
 dedicated surgeon prior to enrollment.

 A)Localized, potentially resectable : 1) no evidence of tumor extension to the celiac
 axis, hepatic artery or superior mesenteric artery; 2) no evidence of tumor encasement
 or occlusion of superior mesenteric vein (SMV) or the SMV/portal vein(PV) confluence;
 3) no evidence of visceral or peritoneal metastasis

 B)Borderline resectable: 1) no extra pancreatic disease, (2) the following possible
 tumor-vessel relationships: an SMV-PV confluence that can be reconstructed even if
 short segment venous occlusion is present; tumor abutment of the SMA of ≤180°; or
 short segment encasement of the hepatic artery amenable to resection and
 reconstruction.

 Patients with the following radiological criteria are NOT eligible:

 A) Locally advanced disease: (1) no extra pancreatic disease, (2) tumor encasement of
 the SMA or celiac axis defined as tumor involvement of >180° of the arterial
 circumference. B) Radiographic evidence of distant organ or peritoneal metastases.

 3. Age > 18 years.

 4. ECOG performance status 0 and 1.

 5. Patient must have adequate hematological, renal and hepatic function defined as:

 WBC > 2,000 cells/mm3 ANC>1500 cells/mm3 Hemoglobin > 9.0 g/dL Platelets > 100,000
 cells/mm3 Serum creatinine < 1.5 x upper limit of normal (UNL) or a calculated
 creatinine clearance of > 50 mL/min calculated by Cockcroft-Gault method Total
 bilirubin < 2.5 mg/dl AST < 3x upper limits of normal ALT < 3x upper limits of normal

 6. Serum calcium and magnesium levels within limits of normal

 7. Patients may not have any prior therapy for carcinoma of the pancreas, nor prior
 abdominal radiation therapy.

 Exclusion Criteria:

 1. 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.

 2. Psychiatric illness which would prevent the patient from giving informed consent.

 3. Serious medical illness which would limit anticipated survival to < 12 weeks.

 4. 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 six months after the trial.
 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 (men and women) of reproductive potential must
 agree to use an effective method of birth-control while receiving study therapy and
 for six months after completion of therapy.

 5. Inability to swallow medication. Patients should have adequate, unassisted oral
 intake.

 6. Inability to hold still and cooperate during radiotherapy.

 7. Prior history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
 any evidence of interstitial lung disease on baseline chest CT scan.