Adenocarcinoma of the pancreas which is locally advanced/inoperable
Conditions
Interventions
Trade Name: Erbitux
Product Name: Cetuximab
Product Code: Erbitux
Pharmaceutical Form: Solution for infusion
Sponsors
Christie Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histopathological or cytological diagnosis of inoperable, non-metastatic pancreatic adenocarcinoma •Karnofsky Performance (KP) Status 100 - 60 •Age = 18 and estimated life expectancy > 3 months •Adequate haematological function: Haemoglobin = 10g/dl; WBC = 3.0 x 109/l; ANC = 1.5 x 109/l; platelet count = 100,000/mm3 (prior transfusions for patients with low haemoglobin allowed) •Adequate liver function: total bilirubin = 1.5 x ULN; ALT & AST = 1.5 x ULN; ALP = 4 x ULN •Adequate renal function with serum urea & creatinine = 1.5 x ULN and a calculated creatinine clearance (Appendix 2) of > 50 ml/min. If the calculated creatinine clearance is marginally less than > 50 ml/min, an isotopic EDTA clearance test will be performed to confirm the creatinine clearance. •Adequate biliary drainage with no evidence of active uncontrolled infection (patients on prophylactic antibiotics are eligible) •Women of child-bearing potential should have a negative pregnancy test prior to study entry AND be suing an adequate contraception method, which must be continued for 3 months after completion of chemotherapy •Capable of giving informed consent •Following types of interventions are allowed: - non-curative operation (i.e. R2 resection with macroscopic residual disease evident on CT scan or palliative bypass procedure) - stent insertion in the common bile duct •KP Status 60–100 •Patients able to tolerate 3 PET scans Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients with neuroendocrine tumours or lymphoma of the pancreas •Incomplete recovery from previous surgery or unresolved biliary tract obstruction •Patients with metastatic disease •Patients with extensive disease unable to be covered in a radically treatable radiotherapy volume •Previous radiotherapy within treatment field •Relative contraindication to radiotherapy •Previous administration of EGF monoclonal antibodies, EGFR signal transduction inhibitors or EGFR targeted therapy •History of prior malignancy that will interfere with the response evaluation (except cervical carcinoma in-situ treated by cone-biopsy/resection, non-metastatic basal &/or squamous cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously) •Any evidence of severe uncontrolled systemic diseases or laboratory finding that in the view of investigator makes it undesirable for the patient to participate in the trial •Any disorder likely to impact compliance with the protocol •Pregnancy or breast feeding •Patients unable to give informed consent •Patients with other serious co-morbid conditions and/or serious uncontrolled infections •Sexually active males or females of reproductive capacity who are not employing adequate contraception •Patients whose sociological, psychological, familial and geographical conditions do not permit compliance with the protocol •Patients with a haemoglobin level < 10 g / dl •Patients must not have any bleeding disorder nor be on anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the progression free survival rate in patients treated with cetuximab and radiotherapy.; Secondary Objective: To determine the response rate, toxicity of the combined regimen, and clinical benefit response in patients treated with cetuximab and radiotherapy. To assess the value of FDG-PET as a pharmacodynamic marker of tumour response. To evaluate the value of FDG-PET as a prognostic marker. To establish the best time to measure serum protein changes following treatment with concurrent cetuximab and radiation. ;Primary end point(s): To evaluate the progression free survival rate in patients treated with cetuximab and radiotherapy. | — |
Countries
United Kingdom
Outcome results
None listed