Know Cancer

forgot password

A Phase II Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, Panitumumab and External Beam Radiation, in Patients With Localized, Non-Metastatic Pancreatic Adenocarcinoma

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Phase II Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, Panitumumab and External Beam Radiation, in Patients With Localized, Non-Metastatic Pancreatic Adenocarcinoma

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the 3 year progression-free survival of patients with localized, resectable pancreatic cancer

Outcome Description:

To estimate the proportions of patients (with localized, resectable and borderline resectable, non-metastatic pancreatic adenocarcinoma) treated with the study regimen alive at 2-years from the date of registration.

Outcome Time Frame:

2 Years

Safety Issue:


Principal Investigator

Bilal Piperdi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Massachusetts, Worcester


United States: Institutional Review Board

Study ID:




Start Date:

May 2010

Completion Date:

December 2015

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Neoadjuvant
  • Panitumumab
  • Capecitabine
  • Pancreatic Neoplasms



University of Massachusetts Medical School Worcester, Massachusetts  01605