ocally Advanced Pancreatic Cancer: Phase II study of cetuximab and 3-D conformal image-guided radiotherapy (PACER Study) - PACER Study

Christie Hospital NHS Trust0 sites44 target enrollmentSeptember 29, 2006

Overview

No summary available.

Registry

who.int

Start Date

September 29, 2006

End Date

September 15, 2010

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Christie Hospital NHS Trust

•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:

•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