A Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)

Royal Marsden NHS Foundation Trust

Status and phase

Terminated

Phase 2

Conditions

Pancreatic Cancer

Treatments

Other: UFT/ Leucovorin + Cetuximab + Radiotherapy

Other: UFT, Leucovorin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01050426

3065

Details and patient eligibility

About

The purpose is to assess the overall survival of patients receiving either UFT/LV + radiotherapy (RT) or UFT/LV + Cetuximab + RT after neo-adjuvant chemotherapy.

Full description

Locally advanced pancreatic cancer carries a poor prognosis with no survival advantage of CRT over chemotherapy alone. 4 Phase II- III studies patients without disease progression after 3 months of systemic chemotherapy and CRT had a longer survival than those continuing on chemotherapy. Therefore chemotherapy followed by CRT may be a better approach. Also the effect of blocking EGFR will be evaluated in locally advanced pancreatic cancer. Gemcitabine and capecitabine combination will be used as neo-adjuvant chemotherapy.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >18
Histological or cytological diagnosis of adeno- or undifferentiated non-small cell carcinoma of pancreas.
Considered to be unresectable based on following: extensive peri-pancreatic lymph node involvement, encasement or occlusion of the SMV or SMV/portal vein confluence, direct involvement of SMA, coeliac axis, inferior vena cava or aorta.
Performance status 0-2
No evidence of metastatic disease as determined by CT scan/ other investigations
Adequate bone marrow function with platelets>100^9/l; WBC>3x10^9/l;neutrophils> 1.5x10^9/l
Serum bilirubin ,1.5 x ULN and transaminases < 2.5 x ULN
Calculated/measured GFR >50ml/min
No concurrent uncontrolled medical condition
No active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix over the last 10 years
Life expectancy > 3months
Adequate contraceptive precautions
Informed written consent

Exclusion criteria

medical or psychiatric conditions that compromise the patient's ability to give informed consent
Presence of met. disease
Concurrent uncontrolled medical conditions
Any previous chemo/RT or any investigational treatment for advanced pancreatic cancer.
Adjuvant chemo + fluoropyrimidine or gemcitabine within 12months of trial entry
Adjuvant RT with/without chemo for pancreatic cancer.
Pregnancy/breast feeding
Patients with known malabsorption syndromes ro a lack of physical treatment of the upper GI tract.
Patients with a known hypersensitivity to 5-FU or with a DPD deficiency.
Clinically significant CVD